Nutritional formula

ABSTRACT

The present disclosure provides a nutritional formula comprising alpha-lactalbumin enriched whey protein concentrate; lactoferrin; oleic acid-palmitic acid-oleic acid triglyceride; lactose; lutein; docosahexanoic acid; arachidonic acid; galactooligosaccharides; and fructooligosaccharides. The provided nutritional formulas may be useful in providing nutrition and/or promoting postnatal development of a subject (e.g., promoting postnatal development of an infant&#39;s gastrointestinal tract, promoting proper gastrointestinal function, nutrient absorption, proper immune system development, etc.). Also provided are powder forms, reconstituted formulas, kits, methods, and uses that include or involve a nutritional formula described herein.

RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Application, U.S. Ser. No. 63/039,316, filed Jun. 15, 2020,which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

The focal point of infant nutrition is the developing gastrointestinaltract and its response to the infant's feeding. The tolerance of theinfant formula along with the postnatal development of gastrointestinalfunctions, nutrient absorption, immune system development, gut epitheliainteractions, and micro flora maintenance during digestion provide forthe healthy development of the infant. Sufficient intake of protein andof essential amino acids is important for normal growth of infants. Theconsumption of inadequate amounts of even a single essential amino acidmay produce less desirable effects with regard to infant growth. Thus,the presence of an appropriate amount of protein and of essential aminoacids in a bioavailable matrix is important in the development of new orrevised infant formulas. Triglycerides are an important source of lipidsin infant formulas and provide approximately 50% of calories.Triglycerides consist of a glycerol backbone with a fatty acidesterified at each of the three glycerol —OH groups. The positions ofthe fatty acids on the glycerol backbone are designated as SN-1, SN-2,and SN-3. The outer fatty acids (positions SN-1 and SN-3) are readilyhydrolyzed by the pancreatic lipase-colipase enzyme system resulting intwo free fatty acids and an SN-2 monoglyceride. SN-2 monoglycerides arewell absorbed, while the absorption of free fatty acids is dependent ontheir structure. Monounsaturated and polyunsaturated fatty acids arereadily absorbed as are saturated fatty acids 12 carbons in length orless. Long chain saturated free fatty acids, especially palmitic acid(C16:0) and stearic acid (C18:0), form insoluble calcium soaps and arepoorly absorbed, resulting in loss of fatty acids, calcium and calories(Innis, 2011). Human milk triglycerides have relatively high levels ofpalmitic acid, with this fatty acid being primarily in the SN-2position. It is important to develop a nutritional formula whichprovides these types of nutritional, nutraceutical, and gastrointestinalbenefits. It would be beneficial to develop a nutritional formula withimproved tolerance, while providing for nutrition, and promotingpostnatal development of an infant's gastrointestinal tract, nutrientabsorption, and healthy immune system development in a subject.

SUMMARY OF THE INVENTION

The nutritional formula disclosed therein includes skim milk solids anddemineralized whey, which, without wishing to be bound by any particulartheory, support the ease of digestion and full absorption of milkproteins. The inventors posit that oleic acid-palmitic acid-oleic acidtriglyceride, wherein palmitic acid is at the SN-2 position of theglycerol backbone of the triglyceride (“OPO SN-2 oil”), improves theefficiency of fatty acid absorption, improves the digestibility, reducescalcium loss to the infant's stool, reduces the incidence ofconstipation, and improves calcium absorption. The inventors also positthat lactoferrin helps support the infant immune system, intestinaldevelopment, and iron absorption. In addition, the inventors believethat the combination of lutein and docosahexaenoic acid may promoteretinal health and vision development. Docosahexaenoic acid issusceptible to damage by oxidation and degradation, while lutein is anantioxidant. The inventors accordingly believe that lutein may reduceoxidative degradation of docosahexaenoic acid concentrated in theretina, and thus further promote retinal health and vision development.Docosahexaenoic acid and arachidonic acid improve the tolerance andacceptance of the nutritional formula. Prebiotics are thought tomodulate the gut flora, affect diverse gastrointestinal activities, andinfluence inflammatory processes.

A nutritional formula of the present invention provides a subject (e.g.,infant) with nutrients similar to those provided by human breast milkwhile maintaining and promoting gastrointestinal function in the subject(e.g., infant). Specifically, the addition of alpha-lactalbumin isthought to facilitate the absorption of essential minerals, andalpha-lactalbumin provides a well-balanced supply of essential aminoacids to the subject (e.g., a growing infant).

Previous nutritional formulations included beta-casein enriched milkprotein, mildly hydrolyzed milk protein, osteopontin and/orpolydextrose, for example, both osteopontin and polydextrose; orbeta-casein enriched milk protein, mildly hydrolyzed milk protein, andpolydextrose. In contrast, nutritional formulations disclosed herein donot include beta-casein enriched milk protein, mildly hydrolyzed milkprotein, polydextrose, or osteopontin. In some embodiments, thenutritional formulations of the present invention provides nutrition toa subject (e.g., infant), similar to the nutrition provided by humanbreast milk. In one aspect, the present invention provides a nutritionalformula comprising proteins (not including beta-casein enriched milkprotein, mildly hydrolyzed milk protein, or osteopontin), lipids,carbohydrates, lutein, polyunsaturated fatty acids, and prebiotics(e.g., galactooligosaccharides and fructooligosaccharides, but notpolydextrose). The invention provides powder forms of the nutritionalformula, reconstituted formulas, methods of preparing the nutritionalformula, methods of administering the nutritional formula, and kitsuseful for the preparation and administration of the nutritional formulato a subject (e.g., infant). The present invention also provides methodsof preparing the nutritional formula. The nutritional formulas describedherein are useful in methods, uses, and uses in the manufacture of amedicament for providing nutrition and/or promoting postnataldevelopment of a subject (e.g., promoting development of an infant'sgastrointestinal tract, promoting proper gastrointestinal function(e.g., intestinal microbiota), promoting nutrient (e.g., calcium)absorption, promoting immune system development; and/or improving bonestrength, sleep (e.g., sleep patterns), decreased crying (duration,frequency), decreased fussiness, etc) by administering to (feeding) thesubject a nutritional formula described herein.

Specifically, the nutritional formula of the present invention includesingredients for providing nutrition, including, but not limited to,alpha-lactalbumin enriched whey protein concentrate; lactoferrin; oleicacid-palmitic acid-oleic acid triglyceride, wherein palmitic acid is atthe SN-2 position of the glycerol backbone of the triglyceride; lactose(e.g., wherein the lactose is a decreased amount of lactose, compared tothe amount of lactose in standard cow's milk (approximately 55 g/L));lutein; docosahexanoic acid; arachidonic acid; prebiotics selected fromgalactooligosaccharides and fructooligosaccharides; and combinationsthereof. The nutritional formula of the present invention may alsoinclude one or more of the following: linoleic acid, alpha-linolenicacid, vitamins, minerals, nucleotides, biotin, choline, inositol,taurine, and L-carnitine.

Exemplary nutritional formulas disclosed herein include, but are notlimited to, a nutritional formula comprising alpha-lactalbumin enrichedwhey protein concentrate; lactoferrin; oleic acid-palmitic acid-oleicacid triglyceride, wherein palmitic acid is at the SN-2 position of theglycerol backbone of the triglyceride; lactose (e.g., wherein thelactose is a decreased amount of lactose, compared to the amount oflactose in standard cow's milk (approximately 55 g/L)); lutein;docosahexanoic acid; arachidonic acid; galactooligosaccharides; andfructooligosaccharides, and powder forms and reconstituted formulasthereof. The nutritional formula further comprises, in certainembodiments, vitamins, minerals, nucleotides, and combinations (e.g. ora combination) thereof. In certain embodiments, the nutritional formulasdisclosed herein also include one or more of the following: linoleicacid, alpha-linolenic acid, vitamins, minerals, nucleotides, biotin,choline, inositol, taurine, and L-carnitine.

In another aspect, described herein are reconstituted formulas of apowder form of a nutritional formula described herein, reconstitutedwith water to form a ready-to-feed liquid. In some embodiments, thereconstituted formulas disclosed herein are useful in methods, uses, anduses in the manufacture of a medicament for providing nutrition and/orpromoting postnatal development of a subject (e.g., promotingdevelopment of an infant's gastrointestinal tract, promoting propergastrointestinal function (e.g., intestinal microbiota), promotingnutrient (e.g., calcium) absorption, promoting immune systemdevelopment; and/or improving bone strength, sleep (e.g., sleeppatterns), decreased crying (duration, frequency), decreased fussiness,etc.).

In another aspect, described herein are methods of providing nutrition(e.g., feeding) to a subject (e.g., an infant) comprising administering(feeding) the nutritional formula described herein to the subject. Inanother aspect, described herein are methods of providing nutrition to(e.g., feeding) a subject (e.g., an infant) comprising preparing (e.g.,reconstituting) a powdered form of the nutritional formula describedherein with water to form a ready-to-feed liquid, and administering(feeding) the reconstituted formula to a subject. In another aspect,described herein is the nutritional formula provided herein forproviding nutrition as well as promoting development of an infant'sgastrointestinal tract, promoting proper gastrointestinal function(e.g., intestinal microbiota), nutrient (e.g., calcium) absorption,promoting proper immune system development; and/or improving bonestrength, sleep (e.g., sleep patterns), decreased crying (duration,frequency), decreased fussiness, etc). In another aspect, describedherein are uses of the nutritional formulas described herein formethods, uses, and uses in the manufacture of a medicament for providingnutrition as well as promoting postnatal development of thegastrointestinal tract, for example, promoting development of aninfant's gastrointestinal tract, promoting proper gastrointestinalfunction (e.g., intestinal microbiota), promoting nutrient (e.g.,calcium) absorption, promoting proper immune system development; and/orimproving bone strength, sleep (e.g., sleep patterns), decreased crying(duration, frequency), and/or decreased fussiness.

In certain embodiments, the subject being administered a nutritionalformula described herein is a human (e.g., an infant not more than aboutthirty-six (36) months of age, an infant not more than about thirtymonths of age, an infant not more than about two years of age, an infantnot more than about eighteen months of age, an infant not more thanabout one year of age, an infant not more than about six months of age,or a newborn). In certain embodiments, the subject being administered anutritional formula described herein is a non-human animal.

In still another aspect, described herein are kits including a container(e.g., a ridged or flexible container) with a nutritional formuladescribed herein. A kit described herein may include a single serving ormultiple servings (e.g., one or more packages, wherein each packagecomprises approximately 1.0 g to 100 g or 50 g to 100 g, of the powderednutritional formula described herein) of the nutritional formula orreconstituted formula disclosed herein. A kit described herein mayinclude a single serving or multiple servings (e.g., one or morepackages, wherein each package comprises approximately 9 g to 100 g, 18g to 100 g, 36 g to 100 g, 5.0 g to 100 g, or 4.5 g to 100 g, of thepowdered nutritional formula described herein) of the nutritionalformula or reconstituted formula. in certain embodiments, a package(e.g., service) comprises enough powdered formula to produceapproximately 2 oz to 10 oz, approximately 10 oz to 20 oz, approximately20 oz to 30 oz, approximately 30 oz to 40 oz, approximately 40 oz to 50oz, approximately 50 oz to 60 oz, approximately 60 oz to 70 oz,approximately 70 oz to 80 oz, approximately 80 oz to 90 oz,approximately 90 oz to 100 oz, approximately 100 oz to 110 oz,approximately 2 oz to approximately 90 oz, 4 oz to approximately 90 oz,8 oz to approximately 90 oz, or 1 oz to approximately 90 oz, of thereconstituted formula. The embodiment of the kit with a flexible packagemay contain a restriction at the opening end below the tare strip toform a pour spout with an opening smaller than the diameter of a baby(e.g., infant) bottle. The package of the kit may be a unit of usepackage. The kits may have added benefits, for example, the addedbenefit of reducing the contamination of the powder during thereconstitution of the formula. In certain embodiments, a package (e.g.,service) comprises enough powdered formula to produce approximately 0.01L-0.025 L, 0.025 L-0.05 L, or 0.05 L-0.1 L, of the reconstitutedformula. The described kits may be useful in providing nutrition and/orin methods, uses, and uses in the manufacture of a medicament forpromoting postnatal development of a subject (e.g., promotingdevelopment of an infant's gastrointestinal tract, promoting propergastrointestinal function (e.g., intestinal microbiota), promotingnutrient (e.g., calcium) absorption, promoting immune systemdevelopment; and/or improving bone strength, sleep (e.g., sleeppatterns), decreased crying (duration, frequency), decreased fussiness,etc). In certain embodiments, a kit described herein further includesinstructions for using the kit, for example, preparing (e.g.,reconstituting) the powdered formula, administering the formula to asubject (e.g., infant). In still another aspect, described herein aredevices (e.g., bottles) for administering to (e.g., feeding) a subjectthe nutritional formula or reconstituted formula.

The present application refers to various issued patent, publishedpatent applications, journal articles, and other publications, all ofwhich are incorporated herein by reference. The details of one or moreembodiments of the invention are set forth herein. Other features,objects, and advantages of the invention will be apparent from theDetailed Description, the Examples, and the Claims.

Definitions

Definitions of specific terms are described in more detail below.

The term “nutritional formula” as used herein refers to a nutritionalcomposition that is designed for the administration/consumption ofsufficient fats, proteins, carbohydrates, vitamins, minerals,prebiotics, and other nutrients to a subject. The nutritional formulamay be the sole source of nutrition when provided in sufficientquantity. The nutritional formula is suitable for consumption by asubject as described herein, including, but not limited to, infants. Thenutritional formula may come in different forms, including but notlimited to powders, liquids, and liquid concentrates. The terms“consume,” “feed,” “administer,” and conjugations or derivatives thereofrefer to ingesting a nutritional formula or facilitating another'singestion of a nutritional formula, and can be used interchangeably.

The term “formula” encompasses any form of the nutritional formuladescribed herein, including, but not limited to, powder and liquidforms, liquid concentrates, and forms having both liquid and drycomponents. Additionally, the powder can be reconstituted from adehydrated powder form to yield a liquid form suitable for theadministration of the formula to a subject, including an infant.

The term “ready-to-feed” used herein refers to a liquid formula suitablefor administration to a subject (e.g., infant), including reconstitutedpowders, diluted formulas of a concentrated nutritional formula, andmanufactured liquids.

As used herein, concentrations expressed as micrograms per liter(“mcg/L”), milligrams per liter (“mg/L”), and grams per liter (“g/L”)refer to ingredient concentrations within the nutritional formulation ofthe present disclosure (e.g., invention) calculated on a reconstituted,ready-to-feed, or fed basis, unless otherwise specified.

The term “about X,” or “approximately X,” where X is a number orpercentage, refers to a number or percentage that is between 99.5% and100.5%, between 99% and 101%, between 98% and 102%, between 97% and103%, between 96% and 104%, between 95% and 105%, between 92% and 108%,or between 90% and 110%, inclusive, of X.

As used herein, a “subject” is a mammal. In certain embodiments, themammal is an animal. In certain embodiments, the animal is a human. Incertain embodiments, the human is an adult, adolescent, child, toddler,infant, or newborn of either sex. An “infant” or “newborn” refers to ahuman not more than about two years of age. The term “infant” alsoincludes an infant from about 0 to about 4 months of age, from about 4to about 8 months of age, from about 8 to about 12 months of age, fromabout 12 to about 16 months of age, from about 16 to about 18 months ofage, from about 18 to about 24 months of age, from about 24 to about 30months of age, from about 30 months to about 36 months of age, andpreterm infants that are less than about 37 weeks gestational age. A“newborn” is an infant that is not more than about 4 weeks of age, andincludes an infant from about 0 to about 1 week of age, from about 1 toabout 2 weeks of age, from about 2 to about 3 weeks of age, and fromabout 3 to about 4 weeks of age. In certain embodiments, the animal isnon-human. In certain embodiments, the non-human animal is a cow, sheep,buffalo, goat, camel, donkey, horse, or any other non-human animal thatproduces milk. In certain embodiments, the animal is a non-human mammal.In certain embodiments, the animal is a non-human primate.

A “protein,” “peptide,” or “polypeptide” comprises a polymer of aminoacid residues linked together by peptide bonds. The term refers toproteins, polypeptides, and peptides of any size, structure, orfunction. Typically, a protein will be at least three amino acids long.A protein may refer to an individual protein or a collection ofproteins. In certain embodiments, proteins preferably contain onlynatural amino acids, although non-natural amino acids (i.e., compoundsthat do not occur in nature but that can be incorporated into apolypeptide chain) and/or amino acid analogs as are known in the art mayalternatively be employed. Also, one or more of the amino acids in aprotein may be modified, for example, by the addition of a chemicalentity such as a carbohydrate group, a hydroxyl group, a phosphategroup, a farnesyl group, an isofarnesyl group, a fatty acid group, alinker for conjugation or functionalization, or other modification. Aprotein may also be a single molecule or may be a multi-molecularcomplex. A protein may be a fragment of a naturally occurring protein orpeptide. A protein may be naturally occurring, recombinant, synthetic,or any combination of these.

“Whey protein concentrate” is a concentrated form of whey protein. Theterm whey protein concentrate encompasses whey protein of any size,structure, or function, and from any source or any composition. Innutrition, whey protein concentrate may be used to increase dietaryprotein intake. In general, whey protein concentrate contains from about20% to about 90% protein by weight.

“Demineralized whey” or “reduced-minerals whey” refers to, withreference to a purification process, whey protein in which the mineralsand salts (organic and inorganic) have been removed. In someembodiments, between 25-90% of the minerals in the whey protein in thedemineralized whey are removed. In some embodiments, up to 25% of theminerals in the whey protein in the demineralized whey are removed. Insome embodiments, up to 50% of the minerals in the whey protein in thedemineralized whey are removed. In some embodiments, up to 60% of theminerals in the whey protein in the demineralized whey are removed. Insome embodiments, up to 75% of the minerals in the whey protein in thedemineralized whey are removed. In some embodiments, up to 80% of theminerals in the whey protein in the demineralized whey are removed. Insome embodiments, up to 90% of the minerals in the whey protein in thedemineralized whey are removed.

The term “skimmed milk powder” refers to a product that results from theremoval of fat and water from pasteurized milk. The term skimmed milkpowder also encompasses “skim milk powder.” In skimmed milk powder, thefat content or protein content or both in the milk can be altered by theremoval or addition of milk constituents. Milk retentate, milk permeate,and lactose can be used to adjust the skimmed milk powder proteincontent. Skimmed milk powder retains the original whey protein to caseinratio present in the milk. The production of skimmed milk powder ofteninvolves, but is not limited to, the evaporation of moisture from themilk until a dry powder with a low moisture content is obtained. Themilk used to produce the skimmed milk powder as described herein can beobtained from any source. As described herein, skimmed milk powder canbe obtained from any source, most typically from bovine (cow) milk.

“Alpha-lactalbumin” or “α-lactalbumin” is the most abundant protein inhuman breast milk, constituting between about 20% to about 25% of thetotal protein content. The alpha-lactalbumin protein binds divalentcations, such as Ca²⁺ and Zn²⁺, in addition to aiding in the absorptionof essential dietary minerals. Upon digestion within thegastrointestinal tract, alpha-lactalbumin derived peptides may exhibitantibacterial and immune stimulatory properties to protect the subjectagainst infection. As described herein, the alpha-lactalbumin can beobtained from any source, most typically from bovine milk.

The term “enriched” refers to a protein fraction having a high amount ofa specified protein. In some embodiments, a protein fraction enrichedwith a specified protein has at least 30% of the specified protein. Insome embodiments, a protein fraction enriched with a specified proteinhas at least 40% of the specified protein. In some embodiments, aprotein fraction enriched with a specified protein has at least 50% ofthe specified protein. In some embodiments, a protein fraction enrichedwith a specified protein has at least 60% of the specified protein. Insome embodiments, a protein fraction enriched with a specified proteinhas at least 65% of the specified protein. In some embodiments, aprotein fraction enriched with a specified protein has at least 70% ofthe specified protein. In some embodiments, a protein fraction enrichedwith a specified protein has at least 80% of the specified protein. Insome embodiments, a protein fraction enriched with a specified proteinhas at least 90% of the specified protein. “Alpha-lactalbumin enrichedwhey protein concentrate” or “alpha-lactalbumin enhanced whey proteinconcentrate” refers to a whey protein concentrate enriched withalpha-lactalbumin. A whey protein concentrate enriched withalpha-lactalbumin contains more alpha-lactalbumin than a non-enrichedwhey protein concentrate. A whey protein concentrate enriched withalpha-lactalbumin typically contains more than 15% by weight ofalpha-lactalbumin, preferably more than 20% by weight ofalpha-lactalbumin. A whey protein concentrate enriched withalpha-lactalbumin may contain 25%, 30%, 35% or more alpha-lactalbumin byweight, and preferably contains 28% alpha-lactalbumin by weight or more.

“Lactoferrin,” sometimes referred to as “lactotransferrin,” is a proteinproduced during the late stages of pregnancy and is found in breast milkcolostrum and mature breast milk. Lactoferrin is found in the milk ofmany mammals, including in cow milk and in human breast milk.Lactoferrin is classified as a glycoprotein, in which normally about 1to about 4 glycans are attached to amino acid side chains throughout theprotein. Lactoferrin aids in intestinal development and iron absorption,as well as providing immune system support. As described herein, thelactoferrin can be obtained from any source, most typically from bovinemilk.

A “triglyceride” is comprised of three fatty acid chains connected to aglycerol molecule through an ester bond. The term “fat” refers to allfatty acid, triglyceride, lipid, and oil molecules of any size,structure, or function. Typically, a fat is a hydrophobic molecule thatis insoluble in water. An “oil” is generally a mixture of one or moreunsaturated fatty acid chains. A “lipid” is any molecule of a class oforganic compounds that are fatty acids or their derivatives, and areinsoluble in water but soluble in organic compounds, and include manynatural oils, waxes, and steroids. Fats may include fatty acid chainsthat are either saturated or unsaturated. A saturated fat contains nodouble bonds between carbon atoms in the chain. An unsaturated fatcontains one or more double bonds between carbon atoms in the chain, andthe double bond or bonds can be in the cis or trans configuration. Fatscontaining one or more trans double bonds are called trans fats. Fatcontaining one or more cis double bonds are called cis fats. Further, amonounsaturated fatty acid contains at least one double bond betweencarbons in the aliphatic chain. A polyunsaturated fat that contains atleast one aliphatic chains with at least two or more double bondsbetween carbons in the chain. Sources of fat and oils, includingsaturated, unsaturated, and polyunsaturated fat, include, but are notlimited to, canola, sunflower, sesame, peanut, walnut, chia, palm,coconut, avocado, olive, safflower, seaweed, sardine, soybean, tuna,salmon, and whole grain wheat.

The term “unsaturated bond” refers to a double or triple bond.

The term “saturated” refers to a moiety that does not contain a doubleor triple bond, i.e., the moiety only contains single bonds.

A “fatty acid” is an aliphatic carbon chain connected to a carboxylicacid. The term fatty acid refers to fatty acids of any size, structure,or function. The aliphatic carbon chain may be either unsaturated orsaturated. In some embodiments, the fatty acid is not connected to aglycerol backbone. A saturated fatty acid contains no double bondsbetween carbons in the chain. An unsaturated fatty acids contains one ormore double bonds between carbons in the chain, and the double bond orbonds can be cis or trans. A monounsaturated fatty acid contains atleast one double bond between carbons in the aliphatic chain. Apolyunsaturated fatty acid contains at least two or more double bondsbetween carbons in the aliphatic chain. Fatty acids are generallystraight-chained carbons and not branched carbon chains, wherein thenumber of carbon atoms present in the aliphatic chain is from 4 to about28 carbon atoms. Fatty acid chains differ in length, wherein short-chainfatty acids (SCFA) are fatty acids with aliphatic chains of fewer thanabout 6 carbon atoms, wherein medium-chain fatty acids (MCFA) are fattyacids with aliphatic chains of about 6 to about 12 carbon atoms, whereinlong-chain fatty acids (LCFA) are fatty acids with aliphatic chains ofabout 13 to about 21 carbon atoms, and wherein very long-chain fattyacids (VLCFA) are fatty acids with aliphatic chains of about 22 or morecarbon atoms. Non-limiting examples of fatty acids include saturatedfatty acids, including but not limited to, caprylic acid, capric acid,lauric acid, stearic acid, arachidonic acid, behenic acid, lignocericacid, cerotic acid, butyric acid, caproic acid, myristic acid,pentadecanoic acid, palmitic acid, heptadecanoic acid, and arachidicacid; and unsaturated fatty acids, including but not limited to,myristoleic acid, palmitoleic acid, sapienic acid, oleic acid, elaidicacid, vaccenic acid, linoleic acid, linoelaidic acid, α-linolenic acid,γ-linoleneic acid, homogamma-linolenic acid, arachidonic acid,eicosapentaenoic acid, erucic acid, docosahexaenoic acid, pentadecenoicacid, heptadecenoic acid, octadecatetraenoic acid, eicosenoic acid,eicosadienoic acid, eicosatrienoic acid, heneicosapentaenoic acid,behenic acid, docosadienoic acid, docosatrienoic aicd, docosatetraenoicacic, docosapentaenoic acid, lignoceric acid, and nervonic acid; andothers.

Unsaturated fatty acids can be further classified according to thelocation of the double bond in the aliphatic carbon chain. The placementof the double bond is described by the number of the first carbon in thedouble bond, counting from the terminal methyl (—CH₃) of the aliphaticchain according to the formula below:

An “omega-3 fatty acid,” “ω-3 fatty acid,” or “n-3 fatty acid” containsa double bond at carbon 3. An “omega-6 fatty acid,” “ω-6 fatty acid,” or“n-6 fatty acid” contains a double bond at carbon 6. An “omega-9 fattyacid,” “ω-9 fatty acid,” or “n-9 fatty acid” contains a double bond atcarbon 9. An “omega-12 fatty acid,” “ω-12 fatty acid,” or “n-12 fattyacid” contains a double bond at carbon 12.

“Oleic acid” or “C18:1” is a naturally occurring fatty acid in a varietyof animal and vegetable oils. The term oleic acid as described hereinencompasses fatty acids under the IUPAC nomenclature“(9E)-octadec-9-enoic acid.” Oleic acid includes salts or esters ofoleic acid, and oleic acid can be obtained from any source. Oleic acidis further classified as an omega-9 cis monounsaturated fatty acid withone double bond at carbon 9 and a total of 18 carbons in the aliphaticchain (18:1 cis-9). Oleic acid has the chemical formulaCH₃(CH₂)₇CH═CH(CH₂)₇COOH, and the structure

“Palmitic acid” or “C16:0” is the most common fatty acid found inanimals, plants, and microorganisms, such as algae and fungi. The termpalmitic acid as described herein encompasses all fatty acids under theIUPAC nomenclature “hexadecanoic acid.” Palmitic acid includes salts oresters of palmitic acid, and palmitic acid can be obtained from anysource. Palmitic acid is further classified as a saturated fatty acidand consists of a 16 carbon aliphatic chain (16:0). Palmitic acid hasthe chemical formula CH₃(CH₂)₁₄COOH, and the structure

“OPO SN-2 oil,” “SN2 palmitate,” “SN-2 palmitate,” “OPO” or “oleicacid-palmitic acid-oleic acid triglyceride” refers to an oleicacid-palmitic acid-oleic acid triglyceride, wherein palmitic acid is atthe SN-2 position of the glycerol backbone of the triglyceride, andoleic acid is at the SN-1 and SN-3 positions of the glycerol backbone ofthe triglyceride. In some embodiments, the oleic acid-palmiticacid-oleic acid triglyceride is of Formula (I):

wherein R¹ is oleic acid (C18:1), and R² is palmitic acid (C16:0). Insome embodiments, the SN-2 position of the glycerol backbone of thetriglyceride is the second position on the glycerol backbone of thetriglyceride. OPO SN-2 oil may refer to the oleic acid-palmiticacid-oleic acid triglyceride of Formula (I). Optionally, OPO SN-2 oilcomprises OPO triglyceride in an amount of about 50% to about 100% ofthe triglycerides.

“Linoleic acid” or “C18:2” is a fatty acid found in many foods,including many nuts, fatty seeds (such as, but not limited to, flaxseeds, hemp seeds, poppy seeds, sesame seeds, and others), and theirderived vegetable oils. Linoleic acid is one of two essential fattyacids for humans, meaning that it must be obtained through a human'sdiet. The term linoleic acid as described herein encompasses all fattyacids under the IUPAC nomenclature “(9Z,12Z)-octadeca-9,12-dienoicacid,” including, but not limited to, “cis,cis-9,12-octadecadienoicacid,” “18:2 (n-6)”, and “18:2 cis-9,12”. Linoleic acid includes saltsor esters of linoleic acid, and linoleic acid can be derived from anysource. Linoleic acid is further classified as an omega-6 cispolyunsaturated fatty acid with two double bonds at carbons 9 and 12,respectively, and a total of 18 carbons in the aliphatic chain (18:2cis,cis-9,12). Linoleic acid has the chemical formulaCH₃(CH₂)₄CH═CH(CH₂)CH═CH(CH₂)₇COOH, and the structure

“α-linolenic acid” or “alpha-linolenic acid,” sometimes referred to as“ALA,” is a fatty acid found in many seeds and oils, including flaxseed,walnuts, chia, hemp, and many common vegetable oils. Alpha-linolenicacid is an essential fatty acid for humans, meaning that it must beobtained through a human's diet. The term alpha-linolenic acid, asdescribed herein, encompasses all fatty acids under the IUPACnomenclature “(9Z,12Z,15Z)-octadeca-9,12,15-trienoic acid,” including,but not limited to, “ALA,” “LNA” “linolenic acid,”“cis,cis,cis-9,12,15-octadecatrienoic acid,”“all-cis-9,12,15-octadecatrienoic acid,”“(9Z,12Z,15Z)-9,12,15-octadecatrienoic acid” and “Industrene 120.”Alpha-linolenic acid includes salts or esters of alpha-linolenic acid,and alpha-linoleic acid can be derived from any source. Alpha-linolenicacid is further classified as an omega-3 cis polyunsaturated fatty acidwith three double bonds at carbons 9, 12, and 15, respectively, and atotal of 18 carbons in the aliphatic chain (18:3 cis,cis,cis-9,12,15).Alpha-linolenic acid has the chemical formulaCH₃CH₂(CH═CH)CH₂(CH═CH)(CH₂)₇COOH, and the structure

The term “aliphatic” refers to alkyl, alkenyl, alkynyl, and carbocyclicgroups.

The term “alkyl” refers to a radical of a straight-chain or branchedsaturated hydrocarbon group having from 1 to 10 carbon atoms (“C₁₋₁₀alkyl”). In some embodiments, an alkyl group has 1 to 9 carbon atoms(“C₁₋₉ alkyl”). In some embodiments, an alkyl group has 1 to 8 carbonatoms (“C₁₋₈ alkyl”). In some embodiments, an alkyl group has 1 to 7carbon atoms (“C₁₋₇ alkyl”). In some embodiments, an alkyl group has 1to 6 carbon atoms (“C₁₋₆ alkyl”). In some embodiments, an alkyl grouphas 1 to 5 carbon atoms (“C₁₋₅ alkyl”). In some embodiments, an alkylgroup has 1 to 4 carbon atoms (“C₁₋₄ alkyl”). In some embodiments, analkyl group has 1 to 3 carbon atoms (“C₁₋₃ alkyl”). In some embodiments,an alkyl group has 1 to 2 carbon atoms (“C₁₋₂ alkyl”). In someembodiments, an alkyl group has 1 carbon atom (“C₁ alkyl”). In someembodiments, an alkyl group has 2 to 6 carbon atoms (“C₂₋₆ alkyl”).Examples of C₁₋₆ alkyl groups include methyl (C₁), ethyl (C₂), n-propyl(C₃), isopropyl (C₃), n-butyl (C₄), tert-butyl (C₄), sec-butyl (C₄),iso-butyl (C₄), n-pentyl (C₅), 3-pentanyl (C₅), amyl (C₅), neopentyl(C₅), 3-methyl-2-butanyl (C₅), tertiary amyl (C₅), and n-hexyl (C₆).Additional examples of alkyl groups include n-heptyl (C₇), n-octyl (C₈)and the like. Unless otherwise specified, each instance of an alkylgroup is independently unsubstituted (an “unsubstituted alkyl”) orsubstituted (a “substituted alkyl”) with one or more substituents. Incertain embodiments, the alkyl group is an unsubstituted C₁₋₁₀ alkyl(e.g., —CH₃) group. In certain embodiments, the alkyl group is asubstituted C₁₋₁₀ alkyl group.

“Microencapsulated,” “microencapsulation,” or “microcapsule” refers toany substance, particle, or droplet surrounded by a coating of anymaterial to give small capsules or the process of producing suchcapsules. Optionally, the coating material may include a carbohydrate(e.g., ethyl cellulose or sodium alginate), alcohol (e.g., polyvinylalcohol), protein (e.g., sodium alginate), and combinations, or acombination thereof. The term microencapsulated may refer to any foodingredient, enzyme, cell, or other material that may be incorporatedinto the relevant composition, mixture, ingredient, or product.Microencapsulation may be used to enclose any solid, liquid, or gaseoussubstance. Optionally, the microcapsule may be used to enclose anysubstance permanently or temporarily. The term microencapsulation coversall physical, chemical, and physiochemical techniques used in theprocess of generating microcapsules, including pan coating,air-suspension coating, centrifugal extrusion, vibrational nozzle,spray-drying, ionotropic gelation, coacervation-phase separation,interfacial polycondensation, interfacial cross-linking, in-situpolymerization, matrix polymerization, or the combination of techniquesdescribed herein.

“Docosahexaenoic acid” or “DHA” is an omega-3 fatty acid comprising a 22carbon chain and 6 cis double bonds. The terms docosahexaenoic acid andDHA also encompass “cervonic acid,”“all-cis-docosa-4,7,10,13,16,19-hexaenoic acid,” “22:6(n-3),” and anyfatty acid that can be classified under the IUPAC nomenclature“(4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid” and“doconexent”. The terms docosahexaenoic acid and DHA may refer to anydocosahexaenoic acid of any size, structure, or function. Thedocosahexaenoic acid defined herein may be derived from any source,including milk or oil. In certain embodiments, the milk is maternalmilk. In certain embodiments, the oil is fish oil, algae oil, microalgaeoil, fungal oil, and/or any combination thereof. In certain embodiments,the docosahexaenoic acid is sourced from Crypthecodinium cohnii oil. Incertain embodiments, the docosahexaenoic acid is sourced from fish oil.Docosahexaenoic acid has the chemical formulaCH₃CH₂(CH═CH)CH₂(CH═CH)CH₂(CH═CH)CH₂(CH═CH)CH₂(CH═CH)CH₂(CH═CH)(CH₂)₂COOH, and the structure

“Arachidonic acid” or “ARA” is a polyunsaturated omega-6 fatty acidcomprising a 20 carbon aliphatic chain and 4 cis double bonds. The termsarachidonic acid and ARA also encompass“(5Z,8Z,11Z,14Z)-Icosa-5,8,11,14-tetraenoic acid,”“5,8,11,14-all-cis-eicosatetraenoic acid,”“all-cis-5,8,11,14-eicosatetraenoic acid,” “arachidonate,” and any fattyacid that can be classified under the IUPAC nomenclature“(5Z,8Z,11Z,14Z)-5,8,11,14-eicosatetraenoic acid.” Arachidonic acid hasthe chemical formulaCH₃(CH₂)₄(CH═CH)CH₂(CH═CH)CH₂(CH═CH)CH₂(CH═CH)(CH₂)₃COOH, and thestructure

The arachidonic acid may be from any source, including milk and/or oil.In certain embodiments, the milk is bovine milk. In certain embodiments,the oil is fish oil, algae oil, microalgae oil, fungal oil, and/or anycombination thereof. In certain embodiments, the arachidonic acid issourced from Mortierella alpina oil.

A “carbohydrate,” “saccharide,” “sugar,” or “starch” is a moleculecomprised of carbon, hydrogen, and oxygen atoms. The term carbohydraterefers to all carbohydrate, saccharide, sugar, or starch molecules ofany size, structure, or function. A carbohydrate can be amonosaccharide. Two or more monosaccharides may be joined by one or moreglycosidic bonds to produce higher order carbohydrates. A disaccharideis a carbohydrate comprised of two monosaccharides, an oligosaccharideis comprised of about 3 to about 10 monosaccharides, and apolysaccharide is comprised of about 10 or more monosaccharides. Incertain embodiments, the carbohydrate is lactose, maltodextrin, cornsyrup, corn syrup solids, or any combination thereof. In certainembodiments, the carbohydrate is lactose, maltodextrin, or anycombination thereof. In certain embodiments, the carbohydrate islactose.

“Lactose” is a disaccharide carbohydrate. Lactose contains a galactosemoiety and a glucose moiety linked by a glycosidic bond. The termlactose refers to any lactose of any size, structure, or function. Theterm lactose also encompasses “milk sugar,”“4-O-β-D-galactopyranosyl-D-glucose,” and any carbohydrate classifiedunder the IUPAC nomenclature “β-D-galactopyranosyl-(1→4)-D-glucose.”

“Maltodextrin” is a polysaccharide comprising D-glucose units connectedin chains of any length. Optionally, the maltodextrin chain is betweenabout 2 to about 17 glucose units long, and may exists as a mixture ofchain lengths between about 2 to about 17 glucose units long. The termmaltodextrin encompasses any maltodextrin of any size, structure, orfunction, and derived from any source.

An “antioxidant” is a molecule that can prevent the oxidation of anothermolecule. The term antioxidant refers to all antioxidants of any size,structure, or function. An antioxidant functions to prevent chainreactions produced by free radicals, or any atom, ion, or molecule withan unpaired electron, that arise through a variety of natural,biological, and metabolic oxidation reactions. Antioxidants may besulfur-containing compounds, such as glutathione, an enzyme, or adietary antioxidant. Typical dietary antioxidants may include vitamin A,vitamin C, vitamin E, lutein, β-carotene, or others. In certainembodiments, the nutritional formula includes vitamin A, vitamin C,vitamin E, lutein, and/or β-carotene.

“Lutein” is a xanthophyll, a division of the carotenoid group. The termlutein also encompasses “luteine,” “trans-lutein,”“(1R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(1R,4R)-4-hydroxy-2,6,6-trimethylcyclohex-2-en-1-yl]-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-ol,”and “β,ε-carotene-3,3′-diol.” Lutein is synthesized only by plants andis found in high quantities in green leafy vegetables such as spinach,kale, and yellow carrots. Lutein has the chemical structure

“Prebiotic” or “prebiotics” refers to a compound that may induce thegrowth and beneficial activity of host microorganisms, such as bacteria,fungi, or others. A prebiotic refers to all prebiotics of any size,structure, or function. A prebiotic may be from plant or animal sources.In nutrition, a prebiotic is commonly a compound comprising dietaryfiber, wherein the dietary fiber contains a soluble portion and aninsoluble portion, and the fiber aids in digestion. A prebiotic commonlyalters and effects the microorganisms living in the gastrointestinaltract of the host, and often influences microorganisms or microflora inthe gut and elsewhere in the body. Prebiotics suitable for nutritionalformulas include, but are not limited to, galactooligosaccharides,inulin, and fructooligosaccharides. Preferably, the nutritionalcomposition contains galactooligosaccharides, fructooligosaccharides, orany combination thereof. Optionally, the nutritional formula includesgalactooligosaccharides, fructooligosaccharides, and one or moreadditional prebiotics. In some embodiments, the nutritional compositioncontains galactooligosaccharides and fructooligosaccharides.

A “vitamin” is an organic or inorganic compound that is required by anorganism. The term vitamin refers to a vitamin or nutrient of any size,structure, or function. The term vitamin may also refer to a vitaminwithin a complex or coenzyme. Vitamins include compounds required by anorganism that the organism cannot synthesize for itself and must beobtained from the organism's diet. Vitamins also include compoundsrequired by an organism that may be synthesized by the organism itself,may be obtained from the organism's diet, or may be both synthesized bythe organism and obtained from the organism's diet. Vitamins required byhumans may include, but are not limited to, vitamin A, vitamin B₁,vitamin B₂, vitamin B₃, vitamin B₅, vitamin B₆, vitamin B₇, vitamin B₉,vitamin B₁₂, vitamin C, vitamin D₂, vitamin D₃, vitamin E, vitamin K₁,folic acid, inositol, biotin, niacin, and similarly named derivatives orvariants of these named vitamins (e.g., a variant of vitamin E).

A “dietary mineral,” “mineral,” “trace mineral,” “dietary element,” or“mineral nutrient” is any element required by living organisms. The termmineral or dietary mineral refers to a dietary mineral, dietary element,or mineral nutrient of any size, structure, or function. A dietarymineral does not include carbon, hydrogen, oxygen, or nitrogen due totheir presence in common organic molecules. Dietary minerals importantfor humans include, but are not limited to, sulfur, potassium, chloride,sodium, calcium, phosphorous, magnesium, zinc, iron, manganese, copper,iodine, selenium, molybdenum, cobalt, and bromine. A dietary mineral maybe provided in the form of a salt. Non-limiting examples of saltscontaining dietary minerals include sodium chloride, calcium phosphate,calcium carbonate, calcium citrate, potassium chloride, potassiumcitrate, potassium iodide, sodium citrate, sodium selenite, magnesiumphosphate, magnesium chloride, magnesium oxide, iron (II) sulfate, zincsulfate, copper sulfate, and manganese (II) sulfate. In someembodiments, the nutritional composition includes dicalcium phosphate,calcium carbonate, L-choline bitartrate, potassium chloride, magnesiumchloride, sodium citrate, L-carnitine, potassium iodide, potassiumcitrate, dimagnesium phosphate, sodium selenite, trisodium citrate,tripotassium citrate, iron (II) sulfate, zinc sulfate, copper sulfate,and manganese (II) sulfate.

A “nucleotide” is an organic molecule that serves as the basic subunitof nucleic acids, such as deoxyribonucleic acids (DNA) and ribonucleicacids (RNA). The term nucleotide refers to a nucleotide of any size,structure, or function. Nucleotides are typically comprised of anitrogenous base (nucleobase), a 5- or 6-carbon sugar unit, and at leastone phosphate group. Nucleotides serve as energy storage molecules inthe cell, commonly in the form of nucleotide triphosphates, and arecentral to metabolism. The primary nucleobases are cytosine, guanine,adenine, thymine, and uracil. When a nucleobase is connected to a sugarand at least one phosphate group, the nucleotide base is formed. Commonnucleotides include cytidine 5′-monophosphate (CMP), uridine5′-monophosphate (UMP), guanosine 5′-monophosphate (GMP), and adenosine5′-monophosphate (AMP), thymidine 5′-monophosphate (TMP), and saltsthereof, as well as diphosphate and triphosphate analogs, among others.

“Lecithin” is a term used to define any fatty acid or substance thatoccurs naturally in a plant or animal tissue. Lecithin is a yellow-brownamphiphilic substance. In certain embodiments, lecithin may be used forsmoothing food textures, dissolving powders, homogenizing liquidmixtures, repelling sticking materials, and/or as an emulsifier. Theterm lecithin encompasses any lecithin of any size, structure, orfunction, and from any source. In certain embodiments, the sources oflecithin include, but are not limited to, soy, soya, soybeans, eggs,milk, marine sources, rapeseed, cottonseed, and sunflower. In certainembodiments, the lecithin source is soya lecithin.

“L-choline bitartrate” is a water soluble nutrient. L-choline bitartrateis a salt or monoester of choline and tartaric acid. L-cholinebitartrate encompasses any salt containing anN,N,N-trimethylethanolammonium cation and tartaric acid anion. Incertain embodiments, choline bitartrate is a mixture of D/L-cholinebitartrate. L-choline bitartrate contains only the L-enantiomer ofcholine bitartrate. In certain embodiments, L-choline bitartrate isconditioned (e.g., combined) with silica to improve flow characteristicsand handling qualities. In certain embodiments, L-choline bitartrate isconditioned or coated with silica. In certain embodiments, L-cholinebitartrate has the structure:

“L-carnitine” is an amino acid derivative. L-carnitine is involved inlipid and fat metabolism in mammals and other eukaryotes. The termL-carnitine encompasses “3-hydroxy-4-(trimethylazaniumyl)butanoate.”L-carnitine can be from any food, plant, or animal source. In certainembodiments, L-carnitine is from a plant source. In certain embodiments,L-carnitine is from an animal source. L-carnitine comprises exclusively,or is enriched for the L-enantiomer of carnitine.

“Beta-carotene” is a carotene, a class of terpenoids or isoprenoids.Beta-carotene is an organic pigment that has an orange or red color andis abundant in many plants and fruits. Generally, beta-carotene hasabout 40 carbons. The term beta-carotene also encompasses“betacarotene,” “β-carotene,” “Food Orange 5,” “Provitamin A,”“1,1′-(3,7,12,16-Tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis[2,6,6-trimethylcyclohexene],”and“1,3,3-trimethyl-2-[3,7,12,16-tetramethyl-18-(2,6,6-trimethylcyclohex-1-en-1-yl)octadeca-1,3,5,7,9,11,13,15,17-nonaen-1-yl]cyclohex-1-ene.”Beta-carotene can be derived from any food, plant, or animal source. Incertain embodiments, beta-carotene is from a plant source. In certainembodiments, beta-carotene is from an animal source. Beta-carotene hasthe chemical structure

“Taurine” or “2-aminoethanesulfonic acid” is an organic compound thatserves a variety of biological roles, such as conjugation of bile acids,antioxidation, osmoregulation, membrane stabilization, calcium signalingmodulation, development and function of skeletal muscle, development andfunction of the retina, and development and function of the centralnervous system. “Taurine” is also referred to as “2-aminoethanesulfonicacid.” Taurine may be obtained from any source. In certain embodiments,taurine is from an animal source. Taurine has the chemical structure

An “effective amount” of a nutritional formula described herein refersto an amount sufficient to provide nutrition to a subject or to have abiological effect on a subject. An effective amount of a nutritionalformula described herein may vary depending on such factors as thedesired biological endpoint (e.g., promoting to a certain degree thepostnatal development of the gastrointestinal tract, promoting propergastrointestinal function (e.g., intestinal microbiota), promotingnutrient (e.g., calcium) absorption, and/or promoting proper immunesystem development; improving bone strength, sleep (e.g., sleeppatterns), decreased crying (duration, frequency), decreased fussiness,etc), the mode of administration, and the age and health of the subject.In certain embodiments, an effective amount is a nutraceuticallyeffective amount. In certain embodiments, an effective amount is theamount of a nutritional formula described herein in a single serving. Incertain embodiments, an effective amount is the amount of a nutritionalformula described herein in a single feeding. In certain embodiments, aneffective amount is the combined amounts of a nutritional formuladescribed herein in multiple servings. In certain embodiments, aneffective amount is the combined amounts of a nutritional formuladescribed herein in multiple servings (e.g., feedings).

A “nutraceutically effective amount” of a nutritional formula describedherein is an amount sufficient to provide a nutraceutical benefit in thehealth (e.g., gastrointestinal development, nutritional health, nutrientabsorption, immune system development, etc.), of a subject. Anutraceutically effective amount of a nutritional formula means anamount of a nutraceutical agent, alone or in combination with othertherapies, which provides a nutritional benefit in the health of thesubject. The term “nutraceutically effective amount” can encompass anamount that improves overall health, reduces or avoids symptoms, signs,or causes of poor health of the subject, and/or enhances thenutraceutical/nutritional efficacy of another nutritional formula.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings are not intended to be drawn to scale. In theDrawings, for purposes of clarity, not every component may be labeled inevery drawing.

FIGS. 1A and 1B show the manufacturing process for the preparation ofinfant formula in which the formula is prepared through homogenizationand pasteurization.

FIG. 2 shows the manufacturing process for the preparation of infantformula in which the formula is blended and packaged.

FIG. 3 shows the growth chart of animals (body weight by group) in theProtein Efficiency Ratio (PER) study in rats of Example 2 over time.

FIG. 4 is a schematic showing instructions for preparing an exemplaryinfant formula, in which the formula powder is mixed with water.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS OF THE INVENTION

The present disclosure provides, in one aspect, a nutritional formulacomprising alpha-lactalbumin enriched whey protein concentrate;lactoferrin; oleic acid-palmitic acid-oleic acid triglyceride, whereinpalmitic acid is at the SN-2 position of the glycerol backbone of thetriglyceride; lactose; lutein; docosahexanoic acid; arachidonic acid;galactooligosaccharides; and fructooligosaccharides. In certainembodiments, the nutritional formula also comprises additional proteins,nucleotides, vitamins, minerals, and saccharides. The invention providespowdered forms of the nutritional formulas, reconstituted formulas,methods of preparing the nutritional formula, methods of administeringthe nutritional formula, and kits useful for the preparation andadministration of the nutritional formula to a subject (e.g., infant).The nutritional formulas described herein are useful in providingnutrition and/or promoting postnatal development of a subject (e.g.,promoting development of an infant's gastrointestinal tract, promotingproper gastrointestinal function (e.g., intestinal microbiota),promoting nutrient (e.g., calcium) absorption, promoting immune systemdevelopment; improving bone strength, sleep (e.g., sleep patterns),decreased crying (duration, frequency), decreased fussiness, etc.)).Provided are methods of providing nutrition to (e.g., feeding) asubject, by feeding the subject the nutritional formulas describedherein. Also provided are methods of providing nutrition to (e.g.,feeding) a subject, by administering to the subject a nutritionalformula described herein, reconstituted with water. Also provided arekits, methods, and uses including a nutritional formula describedherein.

Nutritional Formulas and Reconstituted Formulations

In one aspect, the present disclosure provides a nutritional formulacomprising:

-   -   a) alpha-lactalbumin enriched whey protein concentrate;    -   b) lactoferrin;    -   c) oleic acid-palmitic acid-oleic acid triglyceride, wherein        palmitic acid is at the SN-2 position of the glycerol backbone        of the triglyceride;    -   d) lactose;    -   e) lutein;    -   f) docosahexanoic acid;    -   g) arachidonic acid;    -   h) galactooligosaccharides; and    -   i) fructooligosaccharides.

The amounts of each of the components of the nutritional formula areprovided herein as values in grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, the amount ofeach component of the nutritional formula in grams per 100 grams ofnutritional formula can be calculated by dividing the value in grams perliter (g/L) of reconstituted, ready-to-use nutritional formula by 1.35.In certain embodiments, the nutritional formula also comprisesadditional proteins, nucleotides, vitamins, minerals, and saccharides.

In certain embodiments, the nutritional formula includes both 1) a wheyprotein concentrate that is not alpha-lactalbumin enriched (e.g., doesnot comprise additional added alpha-lactalbumin); and 2) a whey proteinconcentrate that is alpha-lactalbumin enriched. In certain embodiments,the nutritional formula includes approximately 24.4 grams of a wheyprotein concentrate that is not alpha-lactalbumin enriched, per liter(g/L) of reconstituted, ready-to-use nutritional formula, which isequivalent to approximately 18.1 grams per 100 grams of nutritionalformula. In certain embodiments, the amount of each of the component ofthe nutritional formula in grams per liter (g/L) of reconstituted,ready-to-use nutritional formula includes each component in the form ofsalts, triturated forms, spray dried forms, lyophilized forms, otherforms, and/or combinations thereof.

The nutritional formula also includes an additional whey proteinconcentrate that is not alpha-lactalbumin enriched, in that noadditional alpha-lactalbumin is added to the whey protein concentrate.In certain embodiments, the whey protein concentrate is sourced from anon-human animal (e.g., a cow). In certain embodiments, the whey proteinconcentrate can be obtained from Arla Foods Ingredients Group. Incertain embodiments, none of the whey protein concentrate isalpha-lactalbumin enriched (e.g., the amount of alpha-lactalbumin in thewhey protein concentrate is not above 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%,10%, 12%, 15%, 18%, or 20% by weight of the whey protein concentrate).In certain embodiments, the whey protein concentrate that is notalpha-lactalbumin enriched is present in the weight range fromapproximately 3 grams to approximately 4 grams per liter (g/L),approximately 4 grams to approximately 5 grams per liter (g/L),approximately 5 grams to approximately 6 grams per liter (g/L),approximately 6 grams to approximately 7 grams per liter (g/L),approximately 7 grams to approximately 8 grams per liter (g/L),approximately 8 grams to approximately 8.5 grams per liter (g/L),approximately 8.5 grams to approximately 9.0 grams per liter (g/L),approximately 9.0 grams to approximately 9.5 grams per liter (g/L),approximately 9.5 grams to approximately 10.0 grams per liter (g/L), orapproximately 10.0 grams to approximately 11.0 grams per liter (g/L), ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the whey protein concentrate that is not alpha-lactalbumin enriched ispresent in the weight range from approximately 5 grams to approximately6 grams per liter (g/L), approximately 6 grams to approximately 7 gramsper liter (g/L), approximately 7 grams to approximately 8 grams perliter (g/L), approximately 8 grams to approximately 8.25 grams per liter(g/L), approximately 8.25 grams to approximately 8.5 grams per liter(g/L), approximately 8.5 grams to approximately 9.0 grams per liter(g/L), approximately 9.0 grams to approximately 9.5 grams per liter(g/L), or approximately 9.5 grams to approximately 10.0 grams per liter(g/L), of reconstituted, ready-to-use nutritional formula. In certainembodiments, the whey protein concentrate that is not alpha-lactalbuminenriched is present in the weight range from approximately 8 grams perliter (g/L), approximately 8.1 grams per liter (g/L), or approximately8.2 grams per liter (g/L), of reconstituted, ready-to-use nutritionalformula.

The nutritional formula also includes alpha-lactalbumin enriched wheyprotein concentrate. In certain embodiments, the alpha-lactalbuminenriched whey protein concentrate is sourced from a non-human animal(e.g., a cow). In certain embodiments, the alpha-lactalbumin enrichedwhey protein concentrate is obtained from Arla Foods Ingredients Group.In certain embodiments, approximately 30-50%, approximately 30-35%,approximately 35-40%, approximately 30-40%, approximately 40-50%,approximately 40-45%, approximately 45-50%, approximately 50-55%, orapproximately 55-60%, of the whey protein concentrate isalpha-lactalbumin. In certain embodiments, 40-60% of the whey proteinconcentrate is alpha-lactalbumin. In certain embodiments, approximately40% of the whey protein concentrate is alpha-lactalbumin. In certainembodiments, approximately 43% of the whey protein concentrate isalpha-lactalbumin. In certain embodiments, approximately 46% of the wheyprotein concentrate is alpha-lactalbumin. In certain embodiments,approximately 50% of the whey protein concentrate is alpha-lactalbumin.In certain embodiments, approximately 60% of the whey proteinconcentrate is alpha-lactalbumin. In certain embodiments, thealpha-lactalbumin enriched whey protein concentrate is present in theweight range from approximately 0.25 grams to approximately 5.0 gramsper liter (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the alpha-lactalbumin enriched whey proteinconcentrate is present in the weight range from approximately 0.25 gramsto approximately 5.0 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin enriched whey protein concentrate is present in theweight range from approximately 0.25 grams to approximately 0.5 gramsper liter (g/L), approximately 0.5 grams to approximately 0.75 grams perliter (g/L), approximately 0.5 grams to approximately 1.0 grams perliter (g/L), approximately 1.0 grams to approximately 1.5 grams perliter (g/L), approximately 1.5 grams to approximately 1.75 grams perliter (g/L), approximately 1.75 grams to approximately 2.0 grams perliter (g/L), approximately 1.75 grams to approximately 3.0 grams perliter (g/L), approximately 2.0 grams to approximately 3.0 grams perliter (g/L), approximately 2.0 grams to approximately 2.25 grams perliter (g/L), approximately 2.25 grams to approximately 2.5 grams perliter (g/L), approximately 2.5 grams to approximately 2.75 grams perliter (g/L), approximately 2.75 grams to approximately 3.0 grams perliter (g/L), approximately 3.0 grams to approximately 3.25 grams perliter (g/L), approximately 3.25 grams to approximately 3.5 grams perliter (g/L), approximately 3.5 grams to approximately 3.75 grams perliter (g/L), approximately 3.75 grams to approximately 4.0 grams perliter (g/L), approximately 4.0 grams to approximately 4.25 grams perliter (g/L), approximately 4.25 grams to approximately 4.5 grams perliter (g/L), approximately 4.5 grams to approximately 4.75 grams perliter (g/L), approximately 4.75 grams to approximately 5.0 grams perliter (g/L), approximately 1.75 grams to approximately 5.0 grams perliter (g/L), or approximately 5.0 grams to approximately 5.25 grams perliter (g/L), of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the alpha-lactalbumin enriched whey proteinconcentrate is present in the weight range from approximately 0.5 gramsto approximately 4.0 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin enriched whey protein concentrate is present in theweight range from approximately 2.0 grams to approximately 2.5 grams perliter (g/L), approximately 2.5 grams to approximately 3.0 grams perliter (g/L), approximately 3.0 grams to approximately 5.0 grams perliter (g/L), approximately 0.5 grams to approximately 4.2 grams perliter (g/L), or approximately 3.0 grams to approximately 3.5 grams perliter (g/L), of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the alpha-lactalbumin enriched whey proteinconcentrate is present in the weight range from approximately 2.5 gramsto approximately 3.0 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin enriched whey protein concentrate is present in theweight range from approximately 2.0 grams to approximately 2.5 grams perliter (g/L), approximately 2.5 grams to approximately 2.6 grams perliter (g/L), approximately 2.6 grams to approximately 2.7 grams perliter (g/L), approximately 2.7 grams to approximately 2.8 grams perliter (g/L), approximately 2.8 grams to approximately 2.9 grams perliter (g/L), approximately 2.6 grams to approximately 2.9 grams perliter (g/L), or approximately 3.0 grams to approximately 3.5 grams perliter (g/L), of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the alpha-lactalbumin enriched whey proteinconcentrate is present in the weight range from approximately 2.6 gramsto approximately 2.9 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin enriched whey protein concentrate is present in theweight range from approximately 0.5 grams to approximately 4.0 grams ofalpha-lactalbumin enriched whey protein concentrate per L ofreconstituted, ready-to-use nutritional formula; approximately 2.5 gramsto approximately 3.0 grams of alpha-lactalbumin enriched whey proteinconcentrate per L of reconstituted, ready-to-use nutritional formula; orapproximately 2.6 grams to approximately 2.9 grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the alpha-lactalbumin enriched whey protein concentrate is present inthe weight range from approximately 2.5 grams to approximately 3.0 gramsper liter (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 2.8grams of alpha-lactalbumin enriched whey protein concentrate per liter(g/L) of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 2.715 gramsof alpha-lactalbumin enriched whey protein concentrate per liter (g/L)of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 2.7 grams ofalpha-lactalbumin enriched whey protein concentrate per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 2.7 grams ofalpha-lactalbumin enriched whey protein concentrate per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 2.661 grams ofalpha-lactalbumin enriched whey protein concentrate per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 2.6 grams ofalpha-lactalbumin enriched whey protein concentrate per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 2.577 grams ofalpha-lactalbumin enriched whey protein concentrate per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 2.5 grams ofalpha-lactalbumin enriched whey protein concentrate per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 3.6 grams ofalpha-lactalbumin per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 3.592 grams of alpha-lactalbumin enriched wheyprotein concentrate per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 3.5 grams of alpha-lactalbumin enriched wheyprotein concentrate per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 3.479 grams of alpha-lactalbumin enriched wheyprotein concentrate per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 3.4 grams of alpha-lactalbumin enriched wheyprotein concentrate per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 1.4 grams of alpha-lactalbumin enriched wheyprotein concentrate per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 1.385 grams of alpha-lactalbumin enriched wheyprotein concentrate per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 1.3 grams of alpha-lactalbumin enriched wheyprotein concentrate per liter (g/L) of reconstituted, ready-to-usenutritional formula.

As part of the alpha-lactalbumin enriched whey protein concentrate, thenutritional formula includes alpha-lactalbumin. The alpha-lactalbuminmay be obtained from any source. In certain embodiments, the source ofalpha-lactalbumin within the formula is demineralized whey, whey proteinconcentrate, skimmed milk powder, or alpha-lactalbumin enriched wheyprotein concentrate. In certain embodiments, the alpha-lactalbumin ispresent in the weight range of 0.25 grams to approximately 5.0 grams perliter (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the alpha-lactalbumin is present in the weightrange from approximately 0.25 grams to approximately 4.5 grams per liter(g/L) of reconstituted, ready-to-use nutritional formula. In certainembodiments, the alpha-lactalbumin is present in the weight range fromapproximately 0.25 grams to approximately 4.0 grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the alpha-lactalbumin is present in the weight range from approximately0.25 grams to approximately 0.5 grams per liter (g/L), approximately 0.5grams to approximately 0.75 grams per liter (g/L), approximately 0.5grams to approximately 1.0 grams per liter (g/L), approximately 1.0grams to approximately 1.5 grams per liter (g/L), approximately 1.5grams to approximately 1.75 grams per liter (g/L), approximately 1.75grams to approximately 2.0 grams per liter (g/L), approximately 2.0grams to approximately 2.25 grams per liter (g/L), approximately 2.25grams to approximately 2.5 grams per liter (g/L), approximately 2.5grams to approximately 2.75 grams per liter (g/L), approximately 2.75grams to approximately 3.0 grams per liter (g/L), approximately 3.0grams to approximately 3.25 grams per liter (g/L), approximately 3.25grams to approximately 3.5 grams per liter (g/L), approximately 3.5grams to approximately 3.75 grams per liter (g/L), approximately 3.75grams to approximately 4.0 grams per liter (g/L), or approximately 4.0grams to approximately 4.25 grams per liter (g/L), of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 3.25grams to approximately 3.75 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.25grams to approximately 3.5 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.25grams to approximately 3.0 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.5grams to approximately 3.0 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.25grams to approximately 2.5 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.25grams to approximately 2.0 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.25grams to approximately 1.5 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.5grams to approximately 1.5 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.25grams to approximately 1.0 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.25grams to approximately 0.5 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.25grams to approximately 0.5 grams per liter (g/L), approximately 0.5grams to approximately 1.0 grams per liter (g/L), approximately 1.0grams to approximately 1.2 grams per liter (g/L), approximately 1.2grams to approximately 1.25 grams per liter (g/L), or approximately 1.25grams to approximately 1.5 grams per liter (g/L), of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.5grams to approximately 1.2 grams per liter (g/L), approximately 1.2grams to approximately 1.5 grams per liter (g/L), or approximately 0.75grams to approximately 1.5 grams per liter (g/L), of reconstituted,ready-to-use nutritional formula. In certain embodiments, thealpha-lactalbumin is present in the weight range from approximately 0.5grams to approximately 1.2 grams per liter (g/L), of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 1.2 grams ofalpha-lactalbumin per liter (g/L) of reconstituted, ready-to-usenutritional formula, approximately 1.16 grams of alpha-lactalbumin perliter (g/L) of reconstituted, ready-to-use nutritional formula orapproximately 1.165 grams of alpha-lactalbumin per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 1.165 grams ofalpha-lactalbumin per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulacomprises approximately 0.5 grams to approximately 1.2 grams ofalpha-lactalbumin per 100 grams of nutritional formula in powdered form.In certain embodiments, the nutritional formula comprises approximately0.5 grams to approximately 0.6 grams, approximately 0.6 grams toapproximately 0.7 grams, approximately 0.7 grams to approximately 0.8grams, approximately 0.8 grams to approximately 0.9 grams, approximately0.9 grams to approximately 1.1 grams, or approximately 1.1 grams toapproximately 1.2 grams of alpha-lactalbumin per 100 grams ofnutritional formula in powdered form.

The nutritional formula includes demineralized whey. In certainembodiments, the demineralized whey is present in the weight range fromapproximately 20.0 grams to approximately 21.0 grams per liter (g/L),approximately 21.0 grams to approximately 22.0 grams per liter (g/L),approximately 22.0 grams to approximately 23.0 grams per liter (g/L),approximately 23.0 grams to approximately 23.5 grams per liter (g/L),approximately 23.5 grams to approximately 24.0 grams per liter (g/L),approximately 24.0 grams to approximately 24.5 grams per liter (g/L),approximately 24.0 grams to approximately 25.0 grams per liter (g/L),approximately 25.0 grams to approximately 26.0 grams per liter (g/L),approximately 26.0 grams to approximately 27.0 grams per liter (g/L),approximately 27.0 grams to approximately 28.0 grams per liter (g/L),approximately 28.0 grams to approximately 29.0 grams per liter (g/L),approximately 29.0 grams to approximately 30.0 grams per liter (g/L), orapproximately 30.0 grams to approximately 31.0 grams per liter (g/L), ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the demineralized whey is present in the weight range from approximately22.0 grams to approximately 23.0 grams per liter (g/L), approximately23.0 grams to approximately 23.5 grams per liter (g/L), approximately23.5 grams to approximately 24.0 grams per liter (g/L), approximately24.0 grams to approximately 24.5 grams per liter (g/L), approximately24.0 grams to approximately 25.0 grams per liter (g/L), or approximately25.0 grams to approximately 26.0 grams per liter (g/L), ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the demineralized whey is present in the weight range from approximately20.0 grams to approximately 30.0 grams of demineralized whey per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the demineralized whey is present in the weight range from approximately20.0 grams to approximately 25.0 grams or approximately 25.0 grams toapproximately 30.0 grams of demineralized whey per L of reconstituted,ready-to-use nutritional formula.

The nutritional formula includes skimmed milk powder. In certainembodiments, the skimmed milk powder is produced from skimmed milkprotein. In certain embodiments, the skimmed milk protein is sourcedfrom a non-human animal (e.g., a cow). In certain embodiments, 0.1-5% or5% or less of the skimmed milk powder is water by weight. In certainembodiments, 0.1-1.5%, 0.1-0.5%, 0.5-1%, 1-1.5%, or 1.5% or less of theskimmed milk powder is milkfat by weight. In certain embodiments, 34-60%or 34% or more of the skimmed milk powder is milk protein. In certainembodiments, the skimmed milk powder is present in the weight range fromapproximately 5 grams to approximately 50 grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the skimmed milk powder is present in the weight range fromapproximately 5.0 grams to approximately 10.0 grams per liter (g/L),approximately 5.0 grams to approximately 10.0 grams per liter (g/L),approximately 10.0 grams to approximately 12.0 grams per liter (g/L),approximately 12.0 grams to approximately 14.0 grams per liter (g/L),approximately 14.0 grams to approximately 16.0 grams per liter (g/L),approximately 16.0 grams to approximately 16.5 grams per liter (g/L),approximately 16.5 grams to approximately 17.0 grams per liter (g/L),approximately 17.0 grams to approximately 17.5 grams per liter (g/L),approximately 17.5 grams to approximately 18.0 grams per liter (g/L),approximately 18.0 grams to approximately 18.5 grams per liter (g/L), orapproximately 18.5 grams to approximately 19.0 grams per liter (g/L), ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the skimmed milk powder is present in the weight range fromapproximately 16.5 grams to approximately 18.5 grams of skimmed milkpowder per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the skimmed milk powder is present in the weightrange from approximately 16.0 grams to approximately 19.0 grams ofskimmed milk powder per L (g/L) or approximately 16.0 grams toapproximately 20.0 grams of skimmed milk powder per L (g/L), ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the skimmed milk powder is present in the weight range fromapproximately 10 grams to approximately 20 grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the skimmed milk powder is present in the weight range fromapproximately 5 grams to approximately 15 grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the skimmed milk powder is present in the weight range fromapproximately 5 grams to approximately 10 grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 17.0 grams of skimmedmilk powder per liter (g/L), approximately 17.25 grams of skimmed milkpowder per liter (g/L), or approximately 17.5 grams of skimmed milkpowder per liter (g/L), of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 18 grams of skimmed milk powder per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 17.550 grams of skimmedmilk powder per liter (g/L) of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 17 grams of skimmed milk powder per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 16.780 grams of skimmedmilk powder per liter (g/L) of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 16 grams of skimmed milk powder per liter (g/L) ofreconstituted, ready-to-use nutritional formula.

The nutritional formula also includes lactoferrin. In certainembodiments, the lactoferrin is from a non-human animal (e.g., a cow).In certain embodiments, the lactoferrin can be obtained from IOI LodersCroklaan (Netherlands), Loders Croklaan B.V. (Netherlands), Milei GmbH(Germany), or Kerry (Ireland). In certain embodiments, the lactoferrinis MLF-2M. In certain embodiments, MLF-2M is obtained from Milei GmbH(Germany). In certain embodiments, lactoferrin is present in the weightrange of approximately 0.0002 grams to approximately 0.064 grams perliter (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, lactoferrin is present in the weight range ofapproximately 0.0002 grams to approximately 0.002 grams per liter (g/L),approximately 0.002 grams to approximately 0.02 grams per liter (g/L),approximately 0.02 grams to approximately 0.04 grams per liter (g/L),approximately 0.04 grams to approximately 0.05 grams per liter (g/L),approximately 0.05 grams to approximately 0.06 grams per liter (g/L),approximately 0.06 grams to approximately 0.08 grams per liter (g/L),approximately 0.08 grams to approximately 0.1 grams per liter (g/L),approximately 0.1 grams to approximately 0.13 grams per liter (g/L), orapproximately 0.13 grams to approximately 0.135 grams per liter (g/L),of reconstituted, ready-to-use nutritional formula. In certainembodiments, lactoferrin is present in the weight range of approximately0.05 grams to approximately 0.135 grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,lactoferrin is present in the weight range of approximately 0.01 gramsto approximately 1.5 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, lactoferrin ispresent in the weight range of approximately 0.01 grams to approximately1.0 grams per liter (g/L) of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the lactoferrin is present in theweight range from approximately 0.05 grams to approximately 1.0 gramsper liter (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, lactoferrin is present in the weight range ofapproximately 0.01 grams to approximately 0.5 grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the lactoferrin is present in the weight range from approximately 0.01grams to approximately 0.02 grams per liter (g/L), approximately 0.02grams to approximately 0.03 grams per liter (g/L), approximately 0.03grams to approximately 0.04 grams per liter (g/L), approximately 0.04grams to approximately 0.05 grams per liter (g/L), approximately 0.05grams to approximately 0.06 grams per liter (g/L), approximately 0.06grams to approximately 0.07 grams per liter (g/L), approximately 0.07grams to approximately 0.08 grams per liter (g/L), approximately 0.08grams to approximately 0.09 grams per liter (g/L), approximately 0.09grams to approximately 0.1 grams per liter (g/L), approximately 0.1grams to approximately 0.13 grams per liter (g/L), or approximately 0.13grams to approximately 0.15 grams per liter (g/L), of reconstituted,ready-to-use nutritional formula. In certain embodiments, thelactoferrin is present in the weight range from approximately 0.01 gramsto approximately 0.02 grams per liter (g/L), approximately 0.02 grams toapproximately 0.03 grams per liter (g/L), approximately 0.03 grams toapproximately 0.04 grams per liter (g/L), approximately 0.04 grams toapproximately 0.05 grams per liter (g/L), approximately 0.05 grams toapproximately 0.06 grams per liter (g/L), approximately 0.06 grams toapproximately 0.07 grams per liter (g/L), approximately 0.07 grams toapproximately 0.08 grams per liter (g/L), approximately 0.08 grams toapproximately 0.09 grams per liter (g/L), approximately 0.09 grams toapproximately 0.1 grams per liter (g/L), approximately 0.1 grams toapproximately 0.13 grams per liter (g/L), or approximately 0.13 grams toapproximately 0.15 grams per liter (g/L), approximately 0.13 grams toapproximately 0.16 grams per liter (g/L), or approximately 0.16 grams toapproximately 0.17 grams per liter (g/L), or approximately 0.02 grams toapproximately 0.17 grams per liter (g/L), of reconstituted, ready-to-usenutritional formula. In certain embodiments, the lactoferrin is presentin the weight range from approximately 0.05 grams to approximately 0.2grams per liter (g/L) of reconstituted, ready-to-use nutritionalformula. In certain embodiments, lactoferrin is present in the weightrange of approximately 0.01 grams to approximately 0.1 grams per liter(g/L) of reconstituted, ready-to-use nutritional formula. In certainembodiments, lactoferrin is present in the weight range of approximately0.01 grams to approximately 0.05 grams per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.14 grams of lactoferrin perliter (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately0.135 grams of lactoferrin per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.13 grams of lactoferrin perliter (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.07grams of lactoferrin per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the lactoferrin is presentin the weight range from approximately 0.02 grams to approximately 1.0grams per liter (g/L), approximately 0.02 grams to approximately 0.05grams per liter (g/L), approximately 0.05 grams to approximately 0.10grams per liter (g/L), approximately 0.02 grams to approximately 0.10grams per liter (g/L), approximately 0.1 grams to approximately 0.2grams per liter (g/L), or approximately 0.02 grams to approximately 0.2grams per liter (g/L), per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.06 grams of lactoferrin per liter (g/L) orapproximately 0.07 grams of lactoferrin per liter (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the lactoferrin is present in the weight range from approximately 0.02grams to approximately 1.0 grams per liter (g/L), of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.065 grams of lactoferrinper liter (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately0.064 grams of lactoferrin per liter (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.063 grams of lactoferrinper liter (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.06grams of lactoferrin per liter (g/L) of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.063 grams, 0.133 grams, or 0.162 grams oflactoferrin per liter (g/L) of reconstituted, ready-to-use nutritionalformula.

In one aspect, the present nutritional formula includes a vegetable oilblend. In certain embodiments, the vegetable oil blend includes soybeanoil, soya lecithin, coconut oil, sunflower (non-high Oleic) oil, andcombinations, or a combination thereof. In certain embodiments, thevegetable oil blend includes soybean oil. In certain embodiments, thevegetable oil blend includes soya lecithin. In certain embodiments, thevegetable oil blend includes coconut oil. In certain embodiments, thevegetable oil blend includes oleic acid-palmitic acid-oleic acidtriglyceride, wherein palmitic acid is at the SN-2 position of theglycerol backbone of the triglyceride. In certain embodiments, the oleicacid-palmitic acid-oleic acid triglyceride is of Formula (I):

wherein R¹ is oleic acid (C18:1), and R² is palmitic acid (C16:0). Incertain embodiments, the SN-2 position of the glycerol backbone of thetriglyceride is the second position on the glycerol backbone of thetriglyceride. In certain embodiments, the oleic acid-palmitic acid-oleicacid triglyceride is vegetable-derived. In certain embodiments, theoleic acid-palmitic acid-oleic acid triglyceride is from a vegetable oilblend. In certain embodiments, the oleic acid-palmitic acid-oleic acidtriglyceride is approximately 30% to 50% of a vegetable oil blend. Incertain embodiments, the oleic acid-palmitic acid-oleic acidtriglyceride is from high oleic sunflower oil (e.g., high amounts ofoleic acid, for example, 80% or more oleic acid, in the sunflower oil),palm oil, and combinations, or a combination thereof. In certainembodiments, the oleic acid-palmitic acid-oleic acid triglyceride isfrom sunflower oil. In certain embodiments, the oleic acid-palmiticacid-oleic acid triglyceride is from high oleic sunflower oil. Incertain embodiments, the oleic acid-palmitic acid-oleic acidtriglyceride is from palm oil. In certain embodiments, the vegetable oilblend comprising oleic acid-palmitic acid-oleic acid triglyceride isBetapol DP9100. Betapol DP9100 can be obtained from IOI Loders Croklaan(Netherlands), Loders Croklaan B.V. (Netherlands), and/or Kerry(Ireland). In certain preferred embodiments, the vegetable oil blendcomprising oleic acid-palmitic acid-oleic acid triglyceride is an INFAT®fat blend, which can be obtained from Advanced Lipids (Sweden).

In certain embodiments, the nutritional formula includes the vegetableoil blend in the following weight range, in grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula: approximately 20 gramsto approximately 45 grams of the vegetable oil blend per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 20 grams to approximately22 grams of the vegetable oil blend per L (g/L), approximately 22 gramsto approximately 25 grams of the vegetable oil blend per L (g/L),approximately 25 grams to approximately 27 grams of the vegetable oilblend per L (g/L), approximately 27 grams to approximately 30 grams ofthe vegetable oil blend per L (g/L), approximately 30 grams toapproximately 32 grams of the vegetable oil blend per L (g/L),approximately 32 grams to approximately 35 grams of the vegetable oilblend per L (g/L), approximately 35 grams to approximately 37 grams ofthe vegetable oil blend per L (g/L), approximately 37 grams toapproximately 40 grams of the vegetable oil blend per L (g/L),approximately 40 grams to approximately 42 grams of the vegetable oilblend per L (g/L), or approximately 42 grams to approximately 45 gramsof the vegetable oil blend per L (g/L), of reconstituted, ready-to-usenutritional formula, wherein the triglyceride is vegetable-derived. Incertain embodiments, the nutritional formula includes approximately 20grams to approximately 25 grams of the vegetable oil blend per L (g/L),approximately 25 grams to approximately 30 grams of the vegetable oilblend per L (g/L), approximately 30 grams to approximately 40 grams ofthe vegetable oil blend per L (g/L), approximately 40 grams toapproximately 42 grams of the vegetable oil blend per L (g/L), orapproximately 30.0 grams to approximately 42.0 grams of the vegetableoil blend per L (g/L), of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 30.0 grams to approximately 42.0 grams of the vegetableoil blend per L (g/L), of reconstituted, ready-to-use nutritionalformula, wherein the triglyceride is vegetable-derived. In certainembodiments, the nutritional formula includes approximately 30.0 gramsto approximately 42.0 grams of a vegetable oil blend comprising oleicacid-palmitic acid-oleic acid triglyceride; in which approximately 3.0grams to approximately 7.0 grams of the vegetable oil blend is oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 30.0 grams to approximately42.0 grams of a vegetable oil blend comprising oleic acid-palmiticacid-oleic acid triglyceride; in which approximately 3.0 grams toapproximately 7.0 grams of the vegetable oil blend is oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula, wherein the triglyceride isvegetable-derived. In certain embodiments, the nutritional formulaincludes approximately 25 grams to approximately 40 grams of thevegetable oil blend per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 30 grams to approximately 40 grams of the vegetable oilblend per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 35grams to approximately 40 grams of the vegetable oil blend per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 37 grams of the vegetableoil blend per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately36.519 grams of the vegetable oil blend per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 30 grams, approximately 31grams, approximately 32 grams, approximately 33 grams, approximately 34grams, approximately 35 grams, approximately 36 grams, approximately 37grams, approximately 38 grams, approximately 39 grams, or approximately40 grams, of the vegetable oil blend per L (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 36 grams of the vegetable oilblend per L (g/L) of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately36.315 grams of the vegetable oil blend per L (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 35 grams of the vegetable oilblend per L of reconstituted, ready-to-use nutritional formula.

The nutritional formula includes oleic acid-palmitic acid-oleic acidtriglyceride as part of the vegetable oil blend. In certain embodiments,the nutritional formula includes oleic acid-palmitic acid-oleic acidtriglyceride in the following weight range, in grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula: approximately 0.1 gramsto approximately 1.5 grams of oleic acid-palmitic acid-oleic acidtriglyceride or approximately 1.0 grams to approximately 14.0 grams ofoleic acid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.1 grams to approximately0.5 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 0.5 grams to approximately 1.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately1.0 grams to approximately 1.5 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 1.5 grams to approximately2.0 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 2.0 grams to approximately 2.5 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately2.5 grams to approximately 3.0 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 3.0 grams to approximately3.5 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 3.5 grams to approximately 4.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately4.0 grams to approximately 4.25 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 4.25 grams to approximately4.50 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 4.50 grams to approximately 4.75 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately4.75 grams to approximately 5.0 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 5.0 grams to approximately5.25 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 5.25 grams to approximately 5.5 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately5.5 grams to approximately 5.75 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 5.75 grams to approximately6.0 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 6.0 grams to approximately 6.25 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately6.25 grams to approximately 6.5 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 6.75 grams to approximately7.0 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 1.0 grams toapproximately 1.5 grams of oleic acid-palmitic acid-oleic acidtriglyceride per L (g/L), approximately 1.5 grams to approximately 2.0grams of oleic acid-palmitic acid-oleic acid triglyceride per L (g/L),approximately 2.0 grams to approximately 2.5 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately2.5 grams to approximately 3.0 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 3.0 grams to approximately3.5 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 3.5 grams to approximately 4.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately4.0 grams to approximately 4.25 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 4.25 grams to approximately4.50 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 4.50 grams to approximately 4.75 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately4.75 grams to approximately 5.0 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 5.0 grams to approximately5.25 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 5.25 grams to approximately 5.5 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately5.5 grams to approximately 5.75 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 5.75 grams to approximately6.0 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), of reconstituted, ready-to-use nutritional formula.

In certain embodiments, the nutritional formula includes approximately1.0 grams to approximately 2.0 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 2.0 grams to approximately3.0 grams of oleic acid-palmitic acid-oleic acid triglyceride per L(g/L), approximately 3.0 grams to approximately 4.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately4.0 grams to approximately 5.0 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), approximately 5.0 grams to approximately6.0 grams of oleic acid-palmitic acid-oleic acid triglyceride,approximately 6.0 grams to approximately 7.0 grams of oleicacid-palmitic acid-oleic acid triglyceride, approximately 7.0 grams toapproximately 8.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride, approximately 8.0 grams to approximately 9.0 grams ofoleic acid-palmitic acid-oleic acid triglyceride, approximately 9.0grams to approximately 10.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride, approximately 10.0 grams to approximately 11.0 grams ofoleic acid-palmitic acid-oleic acid triglyceride, approximately 11.0grams to approximately 12.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride, approximately 12.0 grams to approximately 13.0 grams ofoleic acid-palmitic acid-oleic acid triglyceride, approximately 13.0grams to approximately 14.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride, approximately 14.0 grams to approximately 14.5 grams ofoleic acid-palmitic acid-oleic acid triglyceride, or approximately 14.5grams to approximately 15.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride, per L (g/L), of reconstituted, ready-to-use nutritionalformula, wherein the palmitic acid is at the SN-2 position of a glycerolbackbone of the triglyceride. In certain embodiments, the nutritionalformula includes approximately 2.0 grams to approximately 3.0 grams ofoleic acid-palmitic acid-oleic acid triglyceride per L (g/L),approximately 3.0 grams to approximately 4.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L), approximately4.0 grams to approximately 5.0 grams of oleic acid-palmitic acid-oleicacid triglyceride per L (g/L), of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.1 grams to approximately 1.25 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.1 grams to approximately1.0 grams of oleic acid-palmitic acid-oleic acid triglyceride per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.1 grams toapproximately 0.75 grams of oleic acid-palmitic acid-oleic acidtriglyceride per L of reconstituted, ready-to-use nutritional formula.In certain embodiments, the nutritional formula includes approximately0.3 grams to approximately 0.6 grams of oleic acid-palmitic acid-oleicacid triglyceride per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.4 grams to approximately 0.6 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.6 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.5 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes oleic acid-palmitic acid-oleic acidtriglyceride in the following weight range, in grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula: approximately 0.5 gramsto approximately 5.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride per L of reconstituted, ready-to-use nutritional formula.In certain embodiments, the nutritional formula includes approximately0.5 grams to approximately 4.5 grams of oleic acid-palmitic acid-oleicacid triglyceride per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.5 grams to approximately 4.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.5 grams to approximately3.5 grams of oleic acid-palmitic acid-oleic acid triglyceride per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.5 grams toapproximately 3.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride per L of reconstituted, ready-to-use nutritional formula.In certain embodiments, the nutritional formula includes approximately0.5 grams to approximately 2.5 grams of oleic acid-palmitic acid-oleicacid triglyceride per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.5 grams to approximately 2.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.5 grams to approximately1.5 grams of oleic acid-palmitic acid-oleic acid triglyceride per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.5 grams toapproximately 1.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride per L of reconstituted, ready-to-use nutritional formula.In certain embodiments, the nutritional formula includes approximately5.0 grams of oleic acid-palmitic acid-oleic acid triglyceride per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 4.5 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 4.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 1.0 grams to approximately6.0 grams, or approximately 6.0 grams to approximately 14.0 grams ofoleic acid-palmitic acid-oleic acid triglyceride, per L ofreconstituted, ready-to-use nutritional formula, wherein the palmiticacid is at the SN-2 position of a glycerol backbone of the triglyceride.In certain embodiments, the nutritional formula includes approximately1.0 grams to approximately 14.0 grams, approximately 1.0 grams toapproximately 14.5 grams, approximately 2.0 grams to approximately 17.5grams, approximately 2.0 grams to approximately 14.5 grams, orapproximately 14.5 grams to approximately 17.5 grams, of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula, wherein the palmitic acid is at theSN-2 position of a glycerol backbone of the triglyceride. In certainembodiments, the nutritional formula includes approximately 3.0 grams toapproximately 7.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride per L, of reconstituted, ready-to-use nutritional formula,wherein the palmitic acid is at the SN-2 position of a glycerol backboneof the triglyceride, wherein the triglyceride is vegetable-derived. Incertain embodiments, the nutritional formula includes approximately 2.0grams to approximately 5.0 grams of oleic acid-palmitic acid-oleic acidtriglyceride per L of reconstituted, ready-to-use nutritional formula.In certain embodiments, the nutritional formula includes approximately1.0 grams to approximately 6.0 grams of oleic acid-palmitic acid-oleicacid triglyceride per L, approximately 2.0 grams to approximately 5.0grams of oleic acid-palmitic acid-oleic acid triglyceride per L, orapproximately 3.0 grams to approximately 7.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L, of reconstituted,ready-to-use nutritional formula, wherein the palmitic acid is at theSN-2 position of a glycerol backbone of the triglyceride. In certainembodiments, the nutritional formula includes approximately 4.8 grams ofoleic acid-palmitic acid-oleic acid triglyceride per L (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 4.84 grams of oleicacid-palmitic acid-oleic acid triglyceride per L (g/L) of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 4.9 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 5.0 grams of oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula.

The present nutritional formula also includes carbohydrates. In certainembodiments, the carbohydrates include lactose. In certain embodiments,the nutritional formula includes a decreased amount of lactose, comparedto the amount of lactose present in standard full-fat milk(approximately 55 g/L), for example, milk from a mammal, e.g., cow'smilk. In certain embodiments, the nutritional formula includes thefollowing weight range of lactose, in grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula: approximately 60 gramsto approximately 80 grams of lactose per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 35 grams of lactose per L(g/L) to approximately 80 grams of lactose per L (g/L), approximately 35grams of lactose per L (g/L) to approximately 40 grams of lactose per L(g/L), approximately 40 grams of lactose per L (g/L) to approximately 45grams of lactose per L (g/L), approximately 35 grams of lactose per L(g/L) to approximately 45 grams of lactose per L (g/L), approximately 40grams of lactose per L (g/L) to approximately 50 grams of lactose per L(g/L), approximately 50 grams of lactose per L (g/L) to approximately 60grams of lactose per L (g/L), approximately 60 grams of lactose per L(g/L) to approximately 70 grams of lactose per L (g/L), approximately 70grams of lactose per L (g/L) to approximately 80 grams of lactose per L(g/L), or approximately 80 grams of lactose per L (g/L) to approximately90 grams of lactose per L (g/L), of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 35 grams of lactose per L (g/L) to approximately80 grams of lactose per L (g/L), approximately 35 grams of lactose per L(g/L) to approximately 40 grams of lactose per L (g/L), approximately 40grams of lactose per L (g/L) to approximately 45 grams of lactose per L(g/L), approximately 35 grams of lactose per L (g/L) to approximately 45grams of lactose per L (g/L), approximately 40 grams of lactose per L(g/L) to approximately 50 grams of lactose per L (g/L), approximately 50grams of lactose per L (g/L) to approximately 60 grams of lactose per L(g/L), approximately 60 grams of lactose per L (g/L) to approximately 65grams of lactose per L (g/L), approximately 65 grams of lactose per L(g/L) to approximately 68 grams of lactose per L (g/L), approximately 68grams of lactose per L (g/L) to approximately 70 grams of lactose per L(g/L), approximately 60 grams of lactose per L (g/L) to approximately 70grams of lactose per L (g/L), approximately 70 grams of lactose per L(g/L) to approximately 80 grams of lactose per L (g/L), approximately 65grams of lactose per L (g/L) to approximately 80 grams of lactose per L(g/L), approximately 80 grams of lactose per L (g/L) to approximately 90grams of lactose per L (g/L), approximately 90 grams of lactose per L(g/L) to approximately 95 grams of lactose per L (g/L), approximately 95grams of lactose per L (g/L) to approximately 98 grams of lactose per L(g/L), or approximately 98 grams of lactose per L (g/L) to approximately99 grams of lactose per L (g/L), of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 60 grams of lactose per L (g/L) to approximately65 grams of lactose per L (g/L), approximately 65 grams of lactose per L(g/L) to approximately 70 grams of lactose per L (g/L), approximately 70grams of lactose per L (g/L) to approximately 72 grams of lactose per L(g/L), approximately 72 grams of lactose per L (g/L) to approximately 75grams of lactose per L (g/L), approximately 75 grams of lactose per L(g/L) to approximately 80 grams of lactose per L (g/L), or approximately70 grams of lactose per L (g/L) to approximately 80 grams of lactose perL (g/L), of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 70 grams toapproximately 80 grams of lactose per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 60 grams to approximately 75 grams of lactose perL of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 65 grams toapproximately 75 grams of lactose per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 70 grams to approximately 75 grams of lactose perL of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 60 grams toapproximately 70 grams of lactose per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 60 grams to approximately 65 grams of lactose perL of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 37 grams orapproximately 37.1 grams of lactose per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 72 grams or approximately 73 grams of lactose perL of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 74 grams oflactose per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately73.71 grams of lactose per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 73 grams of lactose per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 74 grams of lactose per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 72.9 grams of lactose per Lof reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 67.0 grams,approximately 72.9 grams, or approximately 97 grams of lactose per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 67.0 grams of lactose perL of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 72 grams oflactose per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 97grams of lactose per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includes lessthan approximately 55 grams of lactose per L, less than approximately 54grams of lactose per L, less than approximately 53 grams of lactose perL, less than approximately 52 grams of lactose per L, less thanapproximately 50 grams of lactose per L, or less than approximately 45grams of lactose per L, of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 40 grams of lactose per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulacomprises at most 40 grams of lactose, at most 45 grams of lactose, atmost 50 grams of lactose, at most 55 grams of lactose, at most 60 gramsof lactose, at most 70 grams of lactose, at most 80 grams of lactose, atmost 85 grams of lactose, or at most 90 grams of lactose, per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula comprises at most 40 grams of lactose, at most45 grams of lactose, at most 50 grams of lactose, at most 55 grams oflactose, at most 60 grams of lactose, at most 65 grams of lactose, atmost 68 grams of lactose, at most 69 grams of lactose, at most 70 gramsof lactose, at most 72 grams of lactose, at most 80 grams of lactose, atmost 85 grams of lactose, at most 90 grams of lactose, at most 95 gramsof lactose, or at most 98 grams of lactose, per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula comprises at most 85 grams of lactose per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula comprises at most 98 grams of lactose per L ofreconstituted, ready-to-use nutritional formula.

In certain embodiments, the carbohydrates in the nutritional formulainclude maltodextrin. In certain embodiments, the nutritional formulaincludes at least approximately 0.00001 grams of maltodextrin per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.00001 to 0.05 grams(e.g., 10 micrograms to 50 mg) of maltodextrin per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.00001 to 0.00005 grams(e.g., 10 to 50 micrograms) of maltodextrin per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.00003 grams (e.g., 30micrograms) of maltodextrin per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.0000344 grams (e.g., 34.4 micrograms) ofmaltodextrin per L of reconstituted, ready-to-use nutritional formula.In certain embodiments, the nutritional formula includes approximately0.0005 to 0.05 grams (e.g., 0.5 to 50 mg) of maltodextrin per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.01 grams (e.g., 10 mg)of maltodextrin per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.01138 grams (e.g., 11.38 mg) of maltodextrin per L ofreconstituted, ready-to-use nutritional formula.

In certain embodiments, the nutritional formula includes one or moreantioxidants. In certain embodiments, the antioxidants include selenium,and vitamins (e.g., vitamin C, vitamin E) and carotenoids, such asbeta-carotene, lycopene, and/or lutein. In certain embodiments, thenutritional formula includes lutein. In certain embodiments, thenutritional formula includes the following weight range of lutein, ingrams per liter (g/L) of reconstituted, ready-to-use nutritionalformula: approximately 60 micrograms to approximately 0.05 grams oflutein, approximately 0.04 grams to approximately 0.05 grams of lutein,approximately 0.043 grams to approximately 0.05 grams of lutein,approximately 0.05 grams to approximately 0.075 grams of lutein,approximately 0.075 grams to approximately 0.1 grams of lutein,approximately 0.1 grams to approximately 0.15 grams of lutein,approximately 0.15 grams to approximately 0.2 grams of lutein,approximately 0.2 grams to approximately 0.25 grams of lutein,approximately 0.25 grams to approximately 0.28 grams of lutein,approximately 0.28 grams to approximately 0.3 grams of lutein, orapproximately 0.043 grams to approximately 0.28 grams of lutein, per Lof reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes the following weight rangeof lutein, in grams per liter (g/L) of reconstituted, ready-to-usenutritional formula: approximately 60 micrograms to approximately 0.05grams of lutein, approximately 0.01 grams to approximately 0.015 gramsof lutein, approximately 0.015 grams to approximately 0.017 grams oflutein, approximately 0.017 grams to approximately 0.018 grams oflutein, approximately 0.018 grams to approximately 0.02 grams of lutein,approximately 0.04 grams to approximately 0.05 grams of lutein,approximately 0.043 grams to approximately 0.05 grams of lutein,approximately 0.05 grams to approximately 0.075 grams of lutein,approximately 0.075 grams to approximately 0.1 grams of lutein,approximately 0.1 grams to approximately 0.15 grams of lutein,approximately 0.15 grams to approximately 0.2 grams of lutein,approximately 0.2 grams to approximately 0.205 grams of lutein,approximately 0.205 grams to approximately 0.21 grams of lutein,approximately 0.21 grams to approximately 0.22 grams of lutein,approximately 0.2 grams to approximately 0.23 grams of lutein,approximately 0.23 grams to approximately 0.25 grams of lutein,approximately 0.2 grams to approximately 0.25 grams of lutein,approximately 0.25 grams to approximately 0.28 grams of lutein,approximately 0.28 grams to approximately 0.3 grams of lutein, orapproximately 0.043 grams to approximately 0.28 grams of lutein, per Lof reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 0.0025 gramsto approximately 0.05 grams of lutein per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.0025 grams to approximately0.025 grams of lutein per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.015 grams to approximately 0.020 grams of lutein per Lof reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 0.017 gramsof lutein per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately0.0169 grams of lutein per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 60 micrograms to approximately 100 micrograms of luteinper L of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 70micrograms to approximately 100 micrograms of lutein per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 80 micrograms toapproximately 100 micrograms of lutein per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 80 micrograms toapproximately 90 micrograms of lutein per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 70 micrograms toapproximately 90 micrograms of lutein per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 60 micrograms toapproximately 90 micrograms of lutein per L of reconstituted,ready-to-use nutritional formula. In some embodiments, the nutritionalformula includes approximately 86.4 micrograms of lutein per L ofreconstituted, ready-to-use nutritional formula. In some embodiments,the nutritional formula includes approximately 0.015 grams toapproximately 0.021 grams of lutein per L of reconstituted, ready-to-usenutritional formula.

In certain embodiments, the nutritional formula includes polyunsaturatedfatty acids and salts thereof. In certain embodiments, thepolyunsaturated fatty acids include docosahexanoic acid (DHA),arachidonic acid, linoleic acid, alpha-linolenic acid, or a combinationthereof. In certain embodiments, the nutritional formula includesdocosahexanoic acid, arachidonic acid, linoleic acid, andalpha-linolenic acid. The nutritional formula includes a specific ratioof a carotenoid antioxidant (e.g., lutein) to DHA for improvementsincluding promoting postnatal development of the gastrointestinal tract,for example, promoting development of an infant's gastrointestinaltract, proper gastrointestinal function (e.g., intestinal microbiota),promoting nutrient (e.g., calcium) absorption, promoting immune systemdevelopment; and/or improving bone strength, sleep (e.g., sleeppatterns), decreased crying (duration, frequency), decreased fussiness,etc. In certain embodiments, the nutritional formula comprises a luteinto DHA ratio of approximately 0.5 to 1.0, approximately 0.75 to 1.0,approximately 0.8 to 1.0, approximately 1.0 to 1.0, approximately 1.0 to1.1, approximately 1.0 to 0.9, or approximately 1.0 to 0.8. In certainembodiments, the nutritional formula comprises a lutein to DHA ratio ofapproximately 1.0 to 1.0. The rationale for the lutein to DHA ratio ofapproximately 1.0 to 1.0 includes, but is not limited to, providesprotection during the uptake of DHA, as lutein is an antioxidant for DHAhydrolysis. In certain embodiments, the nutritional formula includesdocosahexanoic acid and arachidonic acid. In certain embodiments, thenutritional formula includes a combined fungal oil (e.g., Mortierellaalpina oil) and microalgal oil (e.g., Crypthecodinium cohnii oil), whichcomprises arachidonic acid and docosahexanoic acid in a 2:1 ratio, thatalso includes the antioxidants of ascorbyl palmitate (approximately 250ppm) and tocopherols (approximately 250-500 ppm). In certainembodiments, the nutritional formula includes Crypthecodinium cohniioil, fish oil, or combinations, or powders thereof, which comprises theDHA. In certain embodiments, the nutritional formula includesCrypthecodinium cohnii oil in powdered form. In certain embodiments, theCrypthecodinium cohnii oil is between 15-20% docosahexanoic acid. Incertain embodiments, the Crypthecodinium cohnii oil is between 15-18%docosahexanoic acid. In certain embodiments, the Crypthecodinium cohniioil powder is approximately 19% docosahexanoic acid. In certainembodiments, the nutritional formula includes Crypthecodinium cohniioil. In certain embodiments, the Crypthecodinium cohnii oil is between5-20% docosahexanoic acid. In certain embodiments, the Crypthecodiniumcohnii oil is between 10-15% docosahexanoic acid. In certainembodiments, the Crypthecodinium cohnii oil is between 8-14%docosahexanoic acid. In certain embodiments, the Crypthecodinium cohniioil is approximately 12% docosahexanoic acid. In certain embodiments,the Crypthecodinium cohnii oil is between 15-18% docosahexanoic acid. Incertain embodiments, the Crypthecodinium cohnii oil is approximately 19%docosahexanoic acid. In certain embodiments, the docosahexanoic acid isfrom Crypthecodinium cohnii oil, fish oil, and combinations, or acombination thereof. In certain embodiments, the docosahexanoic acid isfrom Driphorm® SCO DHA 50. In certain embodiments, the docosahexanoicacid is sourced from Martek Biosciences Corporation, NuMega Ingredients,DSM Nutritional Products, and/or Royal DSM. In certain embodiments, thedocosahexanoic acid is sourced from Martek Biosciences Corporation,NuMega Ingredients, DSM Nutritional Products, Royal DSM, and/or thedocosahexanoic acid is formulated as hexane-free Formulaid B. In certainembodiments, the docosahexanoic acid is from Crypthecodinium cohnii oil.In certain embodiments, the docosahexanoic acid is from SchizochytriumSp. oil. In certain embodiments, the docosahexanoic acid is frommicroalgae Schizochytrium Sp. oil. In certain embodiments, thedocosahexanoic acid is from fish oil. In certain embodiments, thedocosahexanoic acid is from algal oil (e.g., microalgal oil, forexample, freshwater microalgal oil). In certain embodiments, thedocosahexanoic acid is from Crypthecodinium cohnii oil, SchizochytriumSp. oil, or fish oil. In certain embodiments, the docosahexanoic acid isnot microencapsulated. In certain embodiments, the arachidonic acid isnot microencapsulated. In certain embodiments, the docosahexanoic acidand arachidonic acid are both not microencapsulated.

In certain embodiments, the nutritional formula includes the followingweight range of docosahexanoic acid and arachidonic acid, in grams perliter (g/L) of reconstituted, ready-to-use nutritional formula:approximately 0.125 grams to approximately 1.5 grams of a combination ofdocosahexanoic acid and arachidonic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes the following weight range ofdocosahexanoic acid and arachidonic acid, in grams per liter (g/L) ofreconstituted, ready-to-use nutritional formula: approximately 0.05grams to approximately 0.1 grams of a combination of docosahexanoic acidand arachidonic acid per L (g/L), approximately 0.1 grams toapproximately 0.15 grams of a combination of docosahexanoic acid andarachidonic acid per L (g/L), approximately 0.15 grams to approximately0.2 grams of a combination of docosahexanoic acid and arachidonic acidper L (g/L), approximately 0.2 grams to approximately 0.25 grams of acombination of docosahexanoic acid and arachidonic acid per L (g/L),approximately 0.25 grams to approximately 0.3 grams of a combination ofdocosahexanoic acid and arachidonic acid per L (g/L), approximately 0.3grams to approximately 0.35 grams of a combination of docosahexanoicacid and arachidonic acid per L (g/L), approximately 0.35 grams toapproximately 0.4 grams of a combination of docosahexanoic acid andarachidonic acid per L (g/L), approximately 0.4 grams to approximately0.45 grams of a combination of docosahexanoic acid and arachidonic acidper L (g/L), approximately 0.45 grams to approximately 0.5 grams of acombination of docosahexanoic acid and arachidonic acid per L (g/L),approximately 0.1 grams to approximately 0.5 grams of a combination ofdocosahexanoic acid and arachidonic acid per L (g/L), approximately 0.5grams to approximately 0.75 grams of a combination of docosahexanoicacid and arachidonic acid per L (g/L), approximately 0.75 grams toapproximately 0.9 grams of a combination of docosahexanoic acid andarachidonic acid per L (g/L), approximately 0.9 grams to approximately1.0 grams of a combination of docosahexanoic acid and arachidonic acidper L (g/L), approximately 1.0 grams to approximately 1.125 grams of acombination of docosahexanoic acid and arachidonic acid per L (g/L),approximately 1.125 grams to approximately 1.5 grams of a combination ofdocosahexanoic acid and arachidonic acid per L (g/L), approximately 1.5grams to approximately 1.75 grams of a combination of docosahexanoicacid and arachidonic acid per L (g/L), approximately 1.75 grams toapproximately 2.0 grams of a combination of docosahexanoic acid andarachidonic acid per L (g/L), of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includes thefollowing weight range of docosahexanoic acid and arachidonic acid, ingrams per liter (g/L) of reconstituted, ready-to-use nutritionalformula: approximately 0.075 grams to approximately 0.125 grams of acombination of docosahexanoic acid and arachidonic acid per L (g/L),approximately 0.125 grams to approximately 0.15 grams of a combinationof docosahexanoic acid and arachidonic acid per L (g/L), approximately0.15 grams to approximately 1.5 grams of a combination of docosahexanoicacid and arachidonic acid per L (g/L), approximately 0.15 grams toapproximately 0.5 grams of a combination of docosahexanoic acid andarachidonic acid per L (g/L), or approximately 0.15 grams toapproximately 0.45 grams of a combination of docosahexanoic acid andarachidonic acid per L (g/L), of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.15 grams to approximately 1.5 grams of a combination ofdocosahexanoic acid and arachidonic acid per L (g/L), of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.2 grams to approximately1.5 grams of a combination of docosahexanoic acid and arachidonic acidper L of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 0.1 grams toapproximately 0.5 grams of a combination of docosahexanoic acid andarachidonic acid per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.15 grams, approximately 0.2 grams, approximately 0.201grams, approximately 0.202 grams, approximately 0.203 grams,approximately 0.204 grams, or approximately 0.205 grams, of acombination of docosahexanoic acid and arachidonic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.205 grams of acombination of docosahexanoic acid and arachidonic acid per L ofreconstituted, ready-to-use nutritional formula.

In certain embodiments, the nutritional formula includes docosahexanoicacid, and/or salt forms (e.g., salts, triturates) thereof. In certainembodiments, the nutritional formula includes approximately 0.001 gramsto approximately 0.005 grams of docosahexanoic acid per L (g/L),approximately 0.005 grams to approximately 0.01 grams of docosahexanoicacid per L (g/L), approximately 0.01 grams to approximately 0.015 gramsof docosahexanoic acid per L (g/L), approximately 0.01 grams toapproximately 0.02 grams of docosahexanoic acid per L (g/L),approximately 0.02 grams to approximately 0.03 grams of docosahexanoicacid per L (g/L), approximately 0.03 grams to approximately 0.04 gramsof docosahexanoic acid per L (g/L), approximately 0.04 grams toapproximately 0.05 grams of docosahexanoic acid per L (g/L),approximately 0.05 grams to approximately 0.06 grams of docosahexanoicacid per L (g/L), approximately 0.06 grams to approximately 0.07 gramsof docosahexanoic acid per L (g/L), approximately 0.07 grams toapproximately 0.08 grams of docosahexanoic acid per L (g/L),approximately 0.08 grams to approximately 0.09 grams of docosahexanoicacid per L (g/L), approximately 0.09 grams to approximately 0.1 grams ofdocosahexanoic acid per L (g/L), approximately 0.1 grams toapproximately 0.11 grams of docosahexanoic acid per L (g/L), orapproximately 0.11 grams to approximately 0.12 grams of docosahexanoicacid per L (g/L), of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.01grams to approximately 0.10 grams of docosahexanoic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.03 grams toapproximately 0.04 grams of docosahexanoic acid per L (g/L),approximately 0.04 grams to approximately 0.05 grams of docosahexanoicacid per L (g/L), approximately 0.05 grams to approximately 0.06 gramsof docosahexanoic acid per L (g/L), approximately 0.06 grams toapproximately 0.07 grams of docosahexanoic acid per L (g/L),approximately 0.07 grams to approximately 0.08 grams of docosahexanoicacid per L (g/L), approximately 0.08 grams to approximately 0.09 gramsof docosahexanoic acid per L (g/L), approximately 0.09 grams toapproximately 0.1 grams of docosahexanoic acid per L (g/L), orapproximately 0.001 grams to approximately 0.01 grams of docosahexanoicacid per L (g/L), of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.05grams to approximately 0.09 grams of docosahexanoic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.05 grams toapproximately 0.08 grams of docosahexanoic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.06 grams to approximately0.07 grams of docosahexanoic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.01 grams to approximately 0.083 grams ofdocosahexanoic acid per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.06 grams to approximately 0.083 grams of docosahexanoicacid per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.06grams of docosahexanoic acid per L (g/L), approximately 0.065 grams ofdocosahexanoic acid per L (g/L), approximately 0.07 grams ofdocosahexanoic acid per L (g/L), approximately 0.075 grams ofdocosahexanoic acid per L (g/L), or approximately 0.08 grams ofdocosahexanoic acid per L (g/L), of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.0675 grams of docosahexanoic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.0681 grams ofdocosahexanoic acid per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.67 grams of docosahexanoic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.060 grams of docosahexanoicacid per L of reconstituted, ready-to-use nutritional formula.

In certain embodiments, the nutritional formula includes the fungal oil,Mortierella alpina oil, which comprises arachidonic acid. In certainembodiments, the arachidonic acid is from Mortierella alpina oil. Incertain embodiments, the nutritional formula includes arachidonic acid,and/or salt forms, or other forms (e.g., triturates) thereof. In certainembodiments, the arachidonic acid is sourced from Martek BiosciencesCorporation (U.S.A.), NuMega Ingredients (Australia), DSM NutritionalProducts (Netherlands), and/or Royal DSM (Netherlands). In certainembodiments, the nutritional formula includes approximately 0.1 grams toapproximately 1.0 grams of arachidonic acid per L (g/L) ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.001 grams toapproximately 0.005 grams of arachidonic acid per L (g/L), approximately0.005 grams to approximately 0.01 grams of arachidonic acid per L (g/L),approximately 0.01 grams to approximately 0.015 grams of arachidonicacid per L (g/L), approximately 0.015 grams to approximately 0.02 gramsof arachidonic acid per L (g/L), approximately 0.02 grams toapproximately 0.05 grams of arachidonic acid per L (g/L), approximately0.05 grams to approximately 0.1 grams of arachidonic acid, approximately0.1 grams to approximately 0.2 grams of arachidonic acid per L (g/L),approximately 0.2 grams to approximately 0.3 grams of arachidonic acidper L (g/L), approximately 0.3 grams to approximately 0.4 grams ofarachidonic acid per L (g/L), approximately 0.4 grams to approximately0.5 grams of arachidonic acid per L (g/L), approximately 0.5 grams toapproximately 0.6 grams of arachidonic acid per L (g/L), approximately0.6 grams to approximately 0.7 grams of arachidonic acid per L (g/L),approximately 0.7 grams to approximately 0.8 grams of arachidonic acidper L (g/L), approximately 0.8 grams to approximately 0.9 grams ofarachidonic acid per L (g/L), or approximately 0.9 grams toapproximately 1.0 grams of arachidonic acid per L (g/L), ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.05 grams toapproximately 0.075 grams of arachidonic acid per L (g/L), approximately0.075 grams to approximately 0.1 grams of arachidonic acid per L (g/L),approximately 0.1 grams to approximately 0.2 grams of arachidonic acidper L (g/L), approximately 0.2 grams to approximately 0.3 grams ofarachidonic acid per L (g/L), approximately 0.3 grams to approximately0.4 grams of arachidonic acid per L (g/L), approximately 0.4 grams toapproximately 0.5 grams of arachidonic acid per L (g/L), approximately0.5 grams to approximately 0.6 grams of arachidonic acid per L (g/L),approximately 0.1 grams to approximately 0.5 grams of arachidonic acidper L (g/L), or approximately 0.001 grams to approximately 0.1 grams ofarachidonic acid per L (g/L), of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.1 grams to approximately 0.5 grams of arachidonic acidper L of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 0.1 grams toapproximately 0.2 grams of arachidonic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.15 grams of arachidonicacid per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.14grams of arachidonic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.13 grams of arachidonic acid per L (g/L),approximately 0.135 grams of arachidonic acid per L (g/L), approximately0.136 grams of arachidonic acid per L (g/L), approximately 0.137 gramsof arachidonic acid per L (g/L), approximately 0.138 grams ofarachidonic acid per L (g/L), approximately 0.139 grams of arachidonicacid per L (g/L), or approximately 0.14 grams of arachidonic acid per L(g/L), of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 0.135 gramsof arachidonic acid per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.137 grams of arachidonic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.2 grams of arachidonic acidper L of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 0.135 gramsof arachidonic acid per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.1 grams of arachidonic acid per L of reconstituted,ready-to-use nutritional formula.

In certain embodiments, the nutritional formula includes linoleic acidand/or salt forms, or other forms (e.g., triturates) thereof. In certainembodiments, the nutritional formula includes approximately 0.25 gramsto approximately 7.0 grams of linoleic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.25 grams to approximately6.0 grams of linoleic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 5.0 grams to approximately 6.0 grams of linoleicacid per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.25grams to approximately 5.0 grams of linoleic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.25 grams toapproximately 4.0 grams of linoleic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.25 grams to approximately3.0 grams of linoleic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.25 grams to approximately 2.0 grams of linoleicacid per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.25grams to approximately 1.0 grams of linoleic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.25 grams toapproximately 0.75 grams of linoleic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.25 grams to approximately0.5 grams of linoleic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.45 grams to approximately 0.5 grams of linoleicacid per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 5.0grams to approximately 6.0 grams of linoleic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 6.0 grams of linoleicacid per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 5.0grams to approximately 6.3 grams of linoleic acid, approximately 5.0grams to approximately 6.2 grams of linoleic acid, approximately 5.3grams to approximately 7.0 grams of linoleic acid, approximately 5.3grams to approximately 6.0 grams of linoleic acid, or approximately 5.3grams to approximately 6.2 grams of linoleic acid per L, approximately5.3 grams to approximately 6.3 grams of linoleic acid, approximately 6.0grams to approximately 6.1 grams of linoleic acid, approximately 6.1grams to approximately 6.3 grams of linoleic acid, approximately 5.7grams to approximately 6.3 grams of linoleic acid, approximately 5.8grams to approximately 6.2 grams of linoleic acid of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula comprises approximately 5.3 grams to approximately6.3 grams of linoleic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 5.967 grams of linoleic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 5.0 grams of linoleicacid per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately5.616 grams of linoleic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 5.3 grams to approximately 6.2 grams of linoleicacid or approximately 5.9 grams or approximately 6.1 grams of linoleicacid per L of reconstituted, ready-to-use nutritional formula, (e.g.,approximately 5.3 grams to approximately 6.2 grams of linoleic acid perL of reconstituted, ready-to-use nutritional formula). In certainembodiments, the nutritional formula includes approximately 5.0 grams toapproximately 6.2 grams of linoleic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 5.3 grams to approximately6.2 grams of linoleic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.45 grams of linoleic acid per L ofreconstituted, ready-to-use nutritional formula.

In certain embodiments, the nutritional formula includes alpha-linolenicacid, and/or salt forms, or other forms (e.g., triturates) thereof. Incertain embodiments, the nutritional formula includes approximately0.020 grams to approximately 0.75 grams of alpha-linolenic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.020 grams toapproximately 0.6 grams of alpha-linolenic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.050 grams to approximately0.6 grams of alpha-linolenic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.075 grams to approximately 0.6 grams ofalpha-linolenic acid per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.1 grams to approximately 0.6 grams of alpha-linolenicacid per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.1grams to approximately 0.6 grams, approximately 0.1 grams toapproximately 0.25 grams, approximately 0.25 grams to approximately 0.4grams, approximately 0.4 grams to approximately 0.55 grams,approximately 0.4 grams to approximately 0.5 grams, approximately 0.5grams to approximately 0.6 grams, approximately 0.4 grams toapproximately 0.6 grams, approximately 0.5 grams to approximately 0.65grams, or approximately 0.25 grams to approximately 0.6 grams ofalpha-linolenic acid per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.25 grams to approximately 0.6 grams of alpha-linolenicacid per L of reconstituted, ready-to-use nutritional formula. Incertain embodiments, the nutritional formula includes approximately 0.2grams to approximately 0.6 grams of alpha-linolenic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.25 grams toapproximately 0.6 grams of alpha-linolenic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.4 grams to approximately0.5 grams of alpha-linolenic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.6 grams of alpha-linolenic acid per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.548 grams ofalpha-linolenic acid per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.5 grams of alpha-linolenic acid per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 0.421 grams ofalpha-linolenic acid per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.42 grams, approximately 0.53 grams, or approximately0.54 grams of alpha-linolenic acid per L of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.4 grams of alpha-linolenic acid per L ofreconstituted, ready-to-use nutritional formula.

In certain embodiments, the prebiotics include galactooligosaccharidesand fructooligosaccharides. In certain embodiments, the nutritionalformula includes approximately 1.75 grams to approximately 3.0 grams perL, approximately 1.75 grams to approximately 5.0 grams per L,approximately 2.0 grams to approximately 3.0 grams per L, approximately2.5 grams to approximately 5.5 grams per L, approximately 3.0 grams toapproximately 5.0 grams per L, or 0.1 grams to approximately 6.0 gramsof prebiotics (e.g., galactooligosaccharides and fructooligosaccharides)per L of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 1.75 gramsto approximately 3.0 grams per L, approximately 1.75 grams toapproximately 5.0 grams per L, approximately 2.0 grams to approximately2.2 grams per L, approximately 2.2 grams to approximately 2.5 grams perL, approximately 2.5 grams to approximately 3.0 grams per L,approximately 2.0 grams to approximately 3.0 grams per L, approximately2.2 grams to approximately 4.0 grams per L, approximately 2.2 grams toapproximately 2.8 grams per L, approximately 2.8 grams to approximately3.0 grams per L, approximately 2.5 grams to approximately 5.5 grams perL, approximately 3.0 grams to approximately 5.0 grams per L,approximately 3.0 grams to approximately 3.5 grams per L, approximately3.5 grams to approximately 4.0 grams per L, approximately 4.0 grams toapproximately 4.15 grams per L, approximately 4.15 grams toapproximately 4.25 grams per L, approximately 4.25 grams toapproximately 4.5 grams per L, approximately 4.5 grams to approximately5.0 grams per L, approximately 5.0 grams to approximately 5.25 grams perL, approximately 5.25 grams to approximately 5.5 grams per L,approximately 2.0 grams to approximately 5.0 grams per L, approximately2.0 grams to approximately 4.5 grams per L, approximately 2.3 grams toapproximately 4.45 grams per L, approximately 2.2 grams to approximately5.5 grams, or 0.1 grams to approximately 6.0 grams of prebiotics (e.g.,galactooligosaccharides, fructooligosaccharides, combinations thereof)per L of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 0.5 grams toapproximately 5.0 grams of prebiotics (e.g., galactooligosaccharides andfructooligosaccharides) per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.5 grams to approximately 4.0 grams of prebiotics (e.g.,galactooligosaccharides and fructooligosaccharides) per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 2.0 grams toapproximately 3.0 grams of prebiotics (e.g., galactooligosaccharides andfructooligosaccharides) per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 2.2 grams to approximately 4.0 grams, of prebiotics (e.g.,galactooligosaccharides, fructooligosaccharides, combinations thereof)per L of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 2.2 grams toapproximately 4.5 grams, or approximately 2.2 grams to approximately 5.5grams of prebiotics (e.g., galactooligosaccharides,fructooligosaccharides, combinations thereof) per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 2.2 grams to approximately4.0 grams of prebiotics (e.g., galactooligosaccharides,fructooligosaccharides, combinations thereof) per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 2.2 grams to approximately4.5 grams of prebiotics (e.g., galactooligosaccharides,fructooligosaccharides, combinations thereof) per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 2.2 grams to approximately5.5 grams of prebiotics (e.g., galactooligosaccharides,fructooligosaccharides, combinations thereof) per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 3.0 grams to approximately4.0 grams of prebiotics (e.g., galactooligosaccharides andfructooligosaccharides) per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 4.0 grams to approximately 5.0 grams of prebiotics (e.g.,galactooligosaccharides and fructooligosaccharides) per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 4 grams of prebiotics(e.g., galactooligosaccharides and fructooligosaccharides) per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 4.185 grams of prebiotics(e.g., galactooligosaccharides and fructooligosaccharides) per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 2.5 grams of prebiotics(e.g., galactooligosaccharides and fructooligosaccharides) per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 2.591 grams of prebiotics(e.g., galactooligosaccharides and fructooligosaccharides) per L ofreconstituted, ready-to-use nutritional formula.

In certain embodiments, the prebiotics include galactooligosaccharides,fructooligosaccharides, or a combination thereof. In certainembodiments, the prebiotics include galactooligosaccharides andfructooligosaccharides. In certain embodiments, thegalactooligosaccharides are sourced from FrieslandCampina (Netherlands).In certain embodiments, the nutritional formula includes approximately0.05 grams to approximately 0.056 grams of galactooligosaccharides per L(g/L), approximately 0.05 grams to approximately 0.6 grams ofgalactooligosaccharides per L (g/L), approximately 0.056 grams toapproximately 0.6 grams of galactooligosaccharides per L (g/L),approximately 0.1 grams to approximately 0.5 grams ofgalactooligosaccharides per L (g/L), approximately 1.0 grams toapproximately 2.0 grams of galactooligosaccharides per L (g/L),approximately 2.0 grams to approximately 3.0 grams ofgalactooligosaccharides per L (g/L), approximately 3.0 grams toapproximately 4.0 grams of galactooligosaccharides per L (g/L),approximately 3.5 grams to approximately 4.5 grams ofgalactooligosaccharides per L (g/L), approximately 4.0 grams toapproximately 4.5 grams of galactooligosaccharides per L (g/L),approximately 4.5 grams to approximately 5.0 grams ofgalactooligosaccharides per L (g/L), approximately 5.0 grams toapproximately 5.4 grams of galactooligosaccharides per L (g/L),approximately 2.0 grams to approximately 4.0 grams ofgalactooligosaccharides per L (g/L), or approximately 0.5 grams toapproximately 5.4 grams of galactooligosaccharides per L (g/L), ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.05 grams toapproximately 0.056 grams of galactooligosaccharides per L (g/L),approximately 0.05 grams to approximately 0.6 grams ofgalactooligosaccharides per L (g/L), approximately 0.056 grams toapproximately 0.6 grams of galactooligosaccharides per L (g/L),approximately 0.1 grams to approximately 0.5 grams ofgalactooligosaccharides per L (g/L), approximately 1.0 grams toapproximately 2.0 grams of galactooligosaccharides per L (g/L),approximately 2.0 grams to approximately 2.1 grams ofgalactooligosaccharides per L (g/L), approximately 2.1 grams toapproximately 2.5 grams of galactooligosaccharides per L (g/L),approximately 2.0 grams to approximately 2.5 grams ofgalactooligosaccharides per L (g/L), approximately 2.5 grams toapproximately 3.0 grams of galactooligosaccharides per L (g/L),approximately 2.0 grams to approximately 3.0 grams ofgalactooligosaccharides per L (g/L), approximately 2.0 grams toapproximately 3.5 grams of galactooligosaccharides per L (g/L),approximately 3.5 grams to approximately 4.0 grams ofgalactooligosaccharides per L (g/L), approximately 3.0 grams toapproximately 4.0 grams of galactooligosaccharides per L (g/L),approximately 3.5 grams to approximately 4.5 grams ofgalactooligosaccharides per L (g/L), approximately 4.0 grams toapproximately 4.5 grams of galactooligosaccharides per L (g/L),approximately 4.5 grams to approximately 5.0 grams ofgalactooligosaccharides per L (g/L), approximately 5.0 grams toapproximately 5.4 grams of galactooligosaccharides per L (g/L),approximately 2.0 grams to approximately 4.0 grams ofgalactooligosaccharides per L (g/L), approximately 2.0 grams toapproximately 4.2 grams of galactooligosaccharides per L (g/L),approximately 2.0 grams to approximately 4.1 grams ofgalactooligosaccharides per L (g/L), approximately 2.0 grams toapproximately 5.0 grams of galactooligosaccharides per L (g/L), orapproximately 0.5 grams to approximately 5.4 grams ofgalactooligosaccharides per L (g/L), of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.1 grams to approximately 10.0 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 1.0 grams to approximately 8.0 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 2.0 grams to approximately 3.5 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 2.0 grams to approximately 4.2 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 2.0 grams to approximately 5.0 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 2.0 grams to approximately 8.0 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 3.0 grams to approximately 8.0 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 3.0 grams to approximately 7.0 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 3.0 grams to approximately 6.0 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 2.0 grams to approximately 5.0 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 3.0 grams to approximately 5.0 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 4 grams of galactooligosaccharides per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 3.915 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 2.1 grams or approximately 2.3 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 2 grams of galactooligosaccharides per L of reconstituted,ready-to-use nutritional formula. In certain embodiments, thenutritional formula includes approximately 2.331 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.1 grams to approximately 1.0 grams offructooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.05 grams to approximately 0.6 grams offructooligosaccharides per L (g/L), approximately 0.056 grams toapproximately 0.6 grams of fructooligosaccharides per L (g/L), orapproximately 1.0 grams to approximately 4.0 grams offructooligosaccharides per L (g/L), of reconstituted, ready-to-usenutritional formula. In certain embodiments, the nutritional formulaincludes approximately 0.1 grams to approximately 1.0 grams offructooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.05 grams to approximately 0.6 grams offructooligosaccharides per L (g/L), approximately 0.056 grams toapproximately 0.6 grams of fructooligosaccharides per L (g/L),approximately 0.1 grams to approximately 0.3 grams offructooligosaccharides per L (g/L), approximately 0.2 grams toapproximately 0.25 grams of fructooligosaccharides per L (g/L),approximately 0.25 grams to approximately 0.3 grams offructooligosaccharides per L (g/L), approximately 0.2 grams toapproximately 0.27 grams of fructooligosaccharides per L (g/L),approximately 0.2 grams to approximately 0.3 grams offructooligosaccharides per L (g/L), approximately 0.3 grams toapproximately 0.4 grams of fructooligosaccharides per L (g/L),approximately 0.4 grams to approximately 0.5 grams offructooligosaccharides per L (g/L), approximately 0.5 grams toapproximately 0.75 grams of fructooligosaccharides per L (g/L),approximately 0.75 grams to approximately 1.0 grams offructooligosaccharides per L (g/L), or approximately 1.0 grams toapproximately 4.1 grams of fructooligosaccharides, approximately 1.0grams to approximately 4.2 grams of fructooligosaccharides, per L (g/L),of reconstituted, ready-to-use nutritional formula. In certainembodiments, the nutritional formula includes approximately 1.0 grams toapproximately 4.1 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.5 grams toapproximately 1.0 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.2 grams toapproximately 0.27 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately approximately 0.2 gramsto approximately 0.42 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.1 grams toapproximately 0.5 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.2 grams toapproximately 0.4 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.2 grams toapproximately 0.3 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.3 grams offructooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.260 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.270 grams offructooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.21 grams or approximately 0.247 grams offructooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.21 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula. In certain embodiments,the nutritional formula includes approximately 0.247 grams offructooligosaccharides per L of reconstituted, ready-to-use nutritionalformula. In certain embodiments, the nutritional formula includesapproximately 0.4 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula.

In certain embodiments, the nutritional formula further includeslinoleic acid, alpha-linolenic acid, vitamins, minerals, nucleotides,and/or combinations thereof. In certain embodiments, the nutritionalformula further includes linoleic acid, alpha-linolenic acid, vitamins,minerals, nucleosides, nucleotides, and/or combinations thereof. Incertain embodiments, the nutritional formula further includes vitamins.In certain embodiments, the vitamins include Vitamin C, Vitamin E,inositol, Vitamin A, niacin, Vitamin D3, pantothenic acid, Vitamin K1,Vitamin B1, Vitamin B2, Vitamin B6, folic acid, biotin, Vitamin B12, ora combination thereof. In certain embodiments, the vitamins includevitamin C, Vitamin E, inositol, Vitamin A, niacin, Vitamin D3,pantothenic acid, Vitamin K1, Vitamin B1, Vitamin B2, Vitamin B6, folicacid, biotin, and Vitamin B12. In certain embodiments, the nutritionalformula further includes minerals. In certain embodiments, the mineralsinclude calcium, potassium, sodium, magnesium, iron, zinc, manganese,copper, iodine, selenium, chloride, and forms thereof (e.g., salts,triturates) and/or combinations thereof. In certain embodiments, theminerals include calcium, potassium, sodium, magnesium, iron, zinc,manganese, copper, iodine, selenium, chloride, and forms (e.g., salts,triturates) thereof. In certain embodiments, the minerals includecalcium phosphate, calcium carbonate, potassium chloride, sodiumcitrate, magnesium phosphate, sodium selenite, iron (II) sulfate, zincsulfate monohydrate, copper sulfate, manganese (II) sulfate monohydrate,or a combination thereof. In certain embodiments, the minerals includecalcium phosphate, calcium carbonate, potassium chloride, sodiumcitrate, magnesium phosphate, sodium selenite, iron (II) sulfate, zincsulfate monohydrate, copper sulfate, and manganese (II) sulfatemonohydrate, or a combination thereof. In certain embodiments, thenutritional formula includes nucleotides. In certain embodiments, thenucleotides include adenosine 5′-monophosphate, cytidine5′-monophosphate, guanosine 5′-monophosphate, uridine 5′-monophosphate,or a combination thereof. In certain embodiments, the nucleotidesinclude adenosine 5′-monophosphate, cytidine 5′-monophosphate, guanosine5′-monophosphate, and uridine 5′-monophosphate. In certain embodiments,the nutritional formula further includes nucleosides, diphosphate forms,and/or triphosphate forms thereof. In certain embodiments, thenutritional formula further includes nucleosides, diphosphate forms,and/or triphosphate forms (e.g., salts) thereof.

In certain embodiments, the nutritional formula further includesL-choline bitartrate, L-carnitine, beta-carotene, taurine, or acombination thereof. In certain embodiments, the nutritional formulaincludes L-choline bitartrate. In certain embodiments, the nutritionalformula includes L-carnitine. In certain embodiments, the nutritionalformula includes beta-carotene. In certain embodiments, the nutritionalformula includes taurine. In certain embodiments, the nutritionalformula further includes approximately 0.1 grams to approximately 0.5grams of L-choline bitartrate, approximately 0.005 grams toapproximately 0.03 grams of L-carnitine, approximately 0.0001 grams toapproximately 0.0007 grams of beta-carotene, and approximately 0.03grams to approximately 0.07 grams of taurine, all per L ofreconstituted, ready-to-use nutritional formula.

In certain embodiments, the nutritional formula further includes

In certain embodiments, the nutritional formula does not includelycopene. In certain embodiments, the nutritional formula furtherincludes optional ingredients, including, but not limited to, colorants,flavors, preservatives, further antioxidants, emulsifying agents,buffers, stabilizers, thickening agents, or a combination thereof.

In certain embodiments, the nutritional formula includes components inthe following weight ranges, in grams per liter (g/L) of reconstituted,ready-to-use nutritional formula:

-   -   a) approximately 3 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 3.0 grams of        alpha-lactalbumin enriched whey protein concentrate per L of        reconstituted, ready-to-use nutritional formula;    -   c) approximately 20.0 grams to approximately 30.0 grams of        demineralized whey per L of reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.5 grams to approximately 18.5 grams of        skimmed milk powder per L of reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.02 grams to approximately 0.10 grams of        lactoferrin per L of reconstituted, ready-to-use nutritional        formula;    -   f) approximately 30.0 grams to approximately 42.0 grams of a        vegetable oil blend comprising oleic acid-palmitic acid-oleic        acid triglyceride; in which approximately 3.0 grams to        approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of        reconstituted, ready-to-use nutritional formula (e.g., wherein        the triglyceride is vegetable-derived);    -   g) approximately 70 grams to approximately 80 grams of lactose        per L of reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.00006 grams to approximately 0.025 grams of        lutein per L of reconstituted, ready-to-use nutritional formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.5 grams of        arachidonic acid per L of reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6 grams linoleic acid        per L of reconstituted, ready-to-use nutritional formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of reconstituted, ready-to-use        nutritional formula;    -   m) approximately 3.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of reconstituted, ready-to-use nutritional        formula; approximately 0.01 grams to approximately 0.05 grams of        inositol per L of reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.02 grams        of Vitamin A per L of reconstituted, ready-to-use nutritional        formula, approximately 0.005 grams to approximately 0.009 grams        of niacin per L of reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.006        grams of Vitamin D3 per L of reconstituted, ready-to-use        nutritional formula; approximately 0.001 grams to approximately        0.005 grams of pantothenic acid per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0005 grams to        approximately 0.0015 grams of Vitamin K1 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0005 grams to        approximately 0.0015 grams of Vitamin B1 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0001 grams to        approximately 0.0008 grams of Vitamin B6 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0001 grams to        approximately 0.002 grams of folic acid per L of reconstituted,        ready-to-use nutritional formula; approximately 0.00001 grams to        approximately 0.004 grams of biotin per L of reconstituted,        ready-to-use nutritional formula; and approximately 0.000001        grams to approximately 0.0005 grams of Vitamin B12 per L of        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.2 grams to approximately 0.5 grams of        trisodium citrate dihydrate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.002 grams to approximately        0.006 grams of dimagnesium phosphate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.002 grams to        approximately 0.005 grams of sodium selenite per L of        reconstituted, ready-to-use nutritional formula; approximately        0.02 grams to approximately 0.06 grams of iron (II) sulfate per        L of reconstituted, ready-to-use nutritional formula;        approximately 0.01 grams to approximately 0.03 grams of zinc        sulfate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.001 grams to approximately 0.004 grams        of copper sulfate per L of reconstituted, ready-to-use        nutritional formula; and approximately 0.001 grams to        approximately 0.003 grams of manganese (II) sulfate per L of        reconstituted, ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.03 grams of cytidine 5′-monophosphate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.001 grams to        approximately 0.006 grams of guanosine 5′-monophosphate per L of        reconstituted, ready-to-use nutritional formula; and        approximately 0.01 grams to approximately 0.03 grams of uridine        5′-monophosphate per L of reconstituted, ready-to-use        nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of reconstituted, ready-to-use        nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of reconstituted, ready-to-use nutritional        formula; approximately 0.03 grams to approximately 0.07 grams of        taurine per L of reconstituted, ready-to-use nutritional        formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of reconstituted, ready-to-use nutritional        formula; and    -   u) maltodextrin (e.g., at least approximately 0.00001 grams        maltodextrin) per L of reconstituted, ready-to-use nutritional        formula.

In certain embodiments, the nutritional formula includes components inthe following weight ranges, in grams per liter (g/L) of reconstituted,ready-to-use nutritional formula:

-   -   a) approximately 3 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 3.0 grams of        alpha-lactalbumin enriched whey protein concentrate per L of        reconstituted, ready-to-use nutritional formula;    -   c) approximately 20.0 grams to approximately 30.0 grams of        demineralized whey per L of reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.5 grams to approximately 18.5 grams of        skimmed milk powder per L of reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.02 grams to approximately 0.10 grams of        lactoferrin per L of reconstituted, ready-to-use nutritional        formula;    -   f) approximately 30.0 grams to approximately 42.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of        reconstituted, ready-to-use nutritional formula (e.g., wherein        the triglyceride is vegetable-derived);    -   g) approximately 70 grams to approximately 80 grams of lactose        per L of reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.00006 grams to approximately 0.025 grams of        lutein per L of reconstituted, ready-to-use nutritional formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.5 grams of        arachidonic acid per L of reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6 grams linoleic acid        per L of reconstituted, ready-to-use nutritional formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of reconstituted, ready-to-use        nutritional formula;    -   m) approximately 3.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of reconstituted, ready-to-use nutritional        formula; approximately 0.01 grams to approximately 0.05 grams of        inositol per L of reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.02 grams        of Vitamin A per L of reconstituted, ready-to-use nutritional        formula, approximately 0.005 grams to approximately 0.009 grams        of niacin per L of reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.006        grams of Vitamin D3 per L of reconstituted, ready-to-use        nutritional formula; approximately 0.001 grams to approximately        0.005 grams of pantothenic acid per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0005 grams to        approximately 0.0015 grams of Vitamin K1 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0005 grams to        approximately 0.0015 grams of Vitamin B1 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0001 grams to        approximately 0.0008 grams of Vitamin B6 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0001 grams to        approximately 0.002 grams of folic acid per L of reconstituted,        ready-to-use nutritional formula; approximately 0.00001 grams to        approximately 0.004 grams of biotin per L of reconstituted,        ready-to-use nutritional formula; and approximately 0.000001        grams to approximately 0.0005 grams of Vitamin B12 per L of        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.2 grams to approximately 0.5 grams of        trisodium citrate dihydrate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.002 grams to approximately        0.006 grams of dimagnesium phosphate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.00002 grams to        approximately 0.00005 grams of sodium selenite per L of        reconstituted, ready-to-use nutritional formula; approximately        0.02 grams to approximately 0.06 grams of iron (II) sulfate per        L of reconstituted, ready-to-use nutritional formula;        approximately 0.01 grams to approximately 0.03 grams of zinc        sulfate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.001 grams to approximately 0.004 grams        of copper sulfate per L of reconstituted, ready-to-use        nutritional formula; and approximately 0.001 grams to        approximately 0.003 grams of manganese (II) sulfate per L of        reconstituted, ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.03 grams of cytidine 5′-monophosphate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.001 grams to        approximately 0.006 grams of guanosine 5′-monophosphate per L of        reconstituted, ready-to-use nutritional formula; and        approximately 0.01 grams to approximately 0.03 grams of uridine        5′-monophosphate per L of reconstituted, ready-to-use        nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of reconstituted, ready-to-use        nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of reconstituted, ready-to-use nutritional        formula; approximately 0.03 grams to approximately 0.07 grams of        taurine per L of reconstituted, ready-to-use nutritional        formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of reconstituted, ready-to-use nutritional        formula.

In certain embodiments, the nutritional formula includes components inthe following weight ranges, in grams per liter (g/L) of reconstituted,ready-to-use nutritional formula:

-   -   a) approximately 3 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of the        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 3.0 grams of        alpha-lactalbumin enriched whey protein concentrate per L of the        reconstituted, ready-to-use nutritional formula;    -   c) approximately 20.0 grams to approximately 30.0 grams of        demineralized whey per L of the reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.5 grams to approximately 18.5 grams of        skimmed milk powder per L of the reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.02 grams to approximately 0.17 grams of        lactoferrin per L of the reconstituted, ready-to-use nutritional        formula;    -   f) approximately 30.0 grams to approximately 42.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of the        reconstituted, ready-to-use nutritional formula;    -   g) approximately 65 grams to approximately 80 grams of lactose        per L of the reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.00006 grams to approximately 0.025 grams of        lutein per L of the reconstituted, ready-to-use nutritional        formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.5 grams of        arachidonic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6.2 grams linoleic        acid per L of the reconstituted, ready-to-use nutritional        formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   m) approximately 2.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.05 grams of inositol per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.02 grams of Vitamin A per L of the reconstituted, ready-to-use        nutritional formula, approximately 0.005 grams to approximately        0.009 grams of niacin per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.006 grams of Vitamin D3 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.001 grams to approximately 0.005 grams of pantothenic acid per        L of the reconstituted, ready-to-use nutritional formula;        approximately 0.0005 grams to approximately 0.0015 grams of        Vitamin K1 per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.0015        grams of Vitamin B1 per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of the reconstituted, ready-to-use nutritional formula;        approximately 0.0001 grams to approximately 0.002 grams of folic        acid per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams of biotin per L of the reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams of Vitamin B12 per L of the        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.2 grams to approximately        0.5 grams of trisodium citrate dihydrate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.006 grams of dimagnesium        phosphate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00002 grams to approximately 0.00005        grams of sodium selenite per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.02 grams to        approximately 0.06 grams of iron (II) sulfate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.01 grams to approximately 0.03 grams of zinc sulfate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.004 grams of copper        sulfate per L of the reconstituted, ready-to-use nutritional        formula; and approximately 0.001 grams to approximately 0.0045        grams of manganese (II) sulfate per L of the reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of cytidine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.006 grams of        guanosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; and approximately 0.01 grams        to approximately 0.03 grams of uridine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of the reconstituted,        ready-to-use nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.03 grams to approximately        0.07 grams of taurine per L of the reconstituted, ready-to-use        nutritional formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of the reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of the reconstituted, ready-to-use        nutritional formula.

In certain embodiments, an exemplary nutritional formula describedherein includes the following components. In certain embodiments, thenutritional formula includes

-   -   a) approximately 3.0 grams to approximately 10.0 grams of whey        protein concentrate per L of reconstituted, ready-to-use        nutritional formula;    -   b) approximately 2.5 grams to approximately 3.0 grams of        alpha-lactalbumin enriched whey protein concentrate per L of        reconstituted, ready-to-use nutritional formula;    -   c) approximately 20.0 grams to approximately 30.0 grams of        demineralized whey per L of reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.5 grams to approximately 18.5 grams of        skimmed milk powder per L of reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.02 grams to approximately 0.17 grams of        lactoferrin per L of reconstituted, ready-to-use nutritional        formula;    -   f) approximately 30.0 grams to approximately 42.0 grams of a        vegetable oil blend comprising oleic acid-palmitic acid-oleic        acid triglyceride; in which approximately 3.0 grams to        approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of        reconstituted, ready-to-use nutritional formula (e.g., wherein        the triglyceride is vegetable-derived);    -   g) approximately 70 grams to approximately 80 grams of lactose        per L of reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.00006 grams to approximately 0.025 grams of        lutein per L of reconstituted, ready-to-use nutritional formula;    -   i) approximately 0.05 grams to approximately 0.1 grams of        docosahexanoic acid per L of reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.2 grams of        arachidonic acid per L of reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5.0 grams to approximately 7.0 grams linoleic        acid per L of reconstituted, ready-to-use nutritional formula;    -   l) approximately 0.4 grams to approximately 0.6 grams        alpha-linolenic acid per L of reconstituted, ready-to-use        nutritional formula;    -   m) approximately 3.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.2 grams to approximately 0.3 grams of        fructooligosaccharides per L of reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C per L of reconstituted, ready-to-use nutritional        formula; approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of reconstituted, ready-to-use nutritional        formula; approximately 0.01 grams to approximately 0.05 grams of        inositol per L of reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.02 grams        of Vitamin A per L of reconstituted, ready-to-use nutritional        formula, approximately 0.005 grams to approximately 0.009 grams        of niacin per L of reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.006        grams (e.g., approximately 10 micrograms to approximately 20        micrograms, 0.005 grams to 0.006 grams, etc.) of Vitamin D3 per        L of reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.005 grams of        pantothenic acid per L of reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.0015 grams of Vitamin K1 per L of reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.0015 grams (e.g., 0.0004 grams to 0.0006 grams, 0.0007 grams        to 0.0013 grams, etc.) of Vitamin B1 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams (e.g., 0.0005 grams to 0.001 grams,        0.00003 to 0.00005 grams, etc.) of Vitamin B2 per L of        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of reconstituted, ready-to-use nutritional formula;        approximately 0.00001 grams to approximately 0.002 grams (e.g.,        0.00001 grams to 0.00003 grams, 0.0005 to 0.0015 grams, etc.) of        folic acid per L of reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams (e.g., 0.00001 grams to 0.00003 grams, 0.002 to 0.004        grams, etc.) of biotin per L of reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams (e.g., 0.000001 grams to 0.000003        grams, 0.0001 to 0.0005 grams, etc.) of Vitamin B12 per L of        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.3 grams to approximately 0.7 grams of calcium        phosphate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.25 grams to approximately 0.75 grams of        calcium carbonate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.5 grams of potassium chloride per L of reconstituted,        ready-to-use nutritional formula; approximately 0.2 grams to        approximately 0.5 grams of sodium citrate per L of        reconstituted, ready-to-use nutritional formula; approximately        0.00003 grams to approximately 0.00005 grams of magnesium        phosphate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.001 grams to approximately 0.005 grams        of sodium selenite per L of reconstituted, ready-to-use        nutritional formula; approximately 0.02 grams to approximately        0.06 grams of iron (II) sulfate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of zinc sulfate monohydrate per L of        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.004 grams of copper sulfate per L        of reconstituted, ready-to-use nutritional formula; and        approximately 0.000001 grams to approximately 0.000003 grams of        manganese (II) sulfate monohydrate per L of reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.005 grams to approximately 0.01 grams of        adenosine 5′-monophosphate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.03 grams of cytidine 5′-monophosphate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.001 grams to        approximately 0.005 grams of guanosine 5′-monophosphate per L of        reconstituted, ready-to-use nutritional formula; and        approximately 0.01 grams to approximately 0.03 grams of uridine        5′-monophosphate per L of reconstituted, ready-to-use        nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of reconstituted, ready-to-use        nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0006 grams of        beta-carotene per L of reconstituted, ready-to-use nutritional        formula; approximately 0.03 grams to approximately 0.07 grams of        taurine per L of reconstituted, ready-to-use nutritional        formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of reconstituted, ready-to-use nutritional        formula.

In certain embodiments, the nutritional formula includes the followingcomponents (e.g., alone, or in combination) in the following weightranges, in grams per liter (g/L) of reconstituted, ready-to-usenutritional formula:

-   -   a) approximately 6 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of the        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 2.9 grams of        alpha-lactalbumin enriched whey protein concentrate per L of the        reconstituted, ready-to-use nutritional formula;    -   c) approximately 22.0 grams to approximately 26.0 grams of        demineralized whey per L of the reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.5 grams to approximately 18.0 grams of        skimmed milk powder per L of the reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.05 grams to approximately 0.17 grams of        lactoferrin per L of the reconstituted, ready-to-use nutritional        formula;    -   f) approximately 33.0 grams to approximately 42.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of the        reconstituted, ready-to-use nutritional formula;    -   g) approximately 65 grams to approximately 98.0 grams of lactose        per L of the reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.0005 grams to approximately 0.003 grams of        lutein per L of the reconstituted, ready-to-use nutritional        formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.3 grams of        arachidonic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6.2 grams linoleic        acid per L of the reconstituted, ready-to-use nutritional        formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   m) approximately 2.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.05 grams of inositol per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.02 grams of Vitamin A per L of the reconstituted, ready-to-use        nutritional formula, approximately 0.005 grams to approximately        0.009 grams of niacin per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.006 grams of Vitamin D3 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.001 grams to approximately 0.005 grams of pantothenic acid per        L of the reconstituted, ready-to-use nutritional formula;        approximately 0.0005 grams to approximately 0.0015 grams of        Vitamin K1 per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.0015        grams of Vitamin B1 per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of the reconstituted, ready-to-use nutritional formula;        approximately 0.0001 grams to approximately 0.002 grams of folic        acid per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams of biotin per L of the reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams of Vitamin B12 per L of the        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.2 grams to approximately        0.5 grams of trisodium citrate dihydrate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.006 grams of dimagnesium        phosphate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00002 grams to approximately 0.00005        grams of sodium selenite per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.02 grams to        approximately 0.06 grams of iron (II) sulfate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.01 grams to approximately 0.03 grams of zinc sulfate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.004 grams of copper        sulfate per L of the reconstituted, ready-to-use nutritional        formula; and approximately 0.001 grams to approximately 0.0045        grams of manganese (II) sulfate per L of the reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of cytidine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.006 grams of        guanosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; and approximately 0.01 grams        to approximately 0.03 grams of uridine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of the reconstituted,        ready-to-use nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.03 grams to approximately        0.07 grams of taurine per L of the reconstituted, ready-to-use        nutritional formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of the reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of the reconstituted, ready-to-use        nutritional formula.

In certain embodiments, the nutritional formula includes the followingcomponents (e.g., alone, or in combination) in the following weightranges, in grams per liter (g/L) of reconstituted, ready-to-usenutritional formula:

-   -   a) approximately 7 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of the        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.6 grams to approximately 2.9 grams of        alpha-lactalbumin enriched whey protein concentrate per L of the        reconstituted, ready-to-use nutritional formula;    -   c) approximately 23.0 grams to approximately 26.0 grams of        demineralized whey per L of the reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.75 grams to approximately 18.0 grams of        skimmed milk powder per L of the reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.06 grams to approximately 0.17 grams of        lactoferrin per L of the reconstituted, ready-to-use nutritional        formula;    -   f) approximately 34.0 grams to approximately 40.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of the        reconstituted, ready-to-use nutritional formula;    -   g) approximately 65 grams to approximately 70.0 grams of lactose        per L of the reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.0006 grams to approximately 0.003 grams of        lutein per L of the reconstituted, ready-to-use nutritional        formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.3 grams of        arachidonic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6.2 grams linoleic        acid per L of the reconstituted, ready-to-use nutritional        formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   m) approximately 2.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.05 grams of inositol per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.02 grams of Vitamin A per L of the reconstituted, ready-to-use        nutritional formula, approximately 0.005 grams to approximately        0.009 grams of niacin per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.006 grams of Vitamin D3 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.001 grams to approximately 0.005 grams of pantothenic acid per        L of the reconstituted, ready-to-use nutritional formula;        approximately 0.0005 grams to approximately 0.0015 grams of        Vitamin K1 per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.0015        grams of Vitamin B1 per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of the reconstituted, ready-to-use nutritional formula;        approximately 0.0001 grams to approximately 0.002 grams of folic        acid per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams of biotin per L of the reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams of Vitamin B12 per L of the        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.2 grams to approximately        0.5 grams of trisodium citrate dihydrate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.006 grams of dimagnesium        phosphate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00002 grams to approximately 0.00005        grams of sodium selenite per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.02 grams to        approximately 0.06 grams of iron (II) sulfate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.01 grams to approximately 0.03 grams of zinc sulfate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.004 grams of copper        sulfate per L of the reconstituted, ready-to-use nutritional        formula; and approximately 0.001 grams to approximately 0.0045        grams of manganese (II) sulfate per L of the reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of cytidine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.006 grams of        guanosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; and approximately 0.01 grams        to approximately 0.03 grams of uridine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of the reconstituted,        ready-to-use nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.03 grams to approximately        0.07 grams of taurine per L of the reconstituted, ready-to-use        nutritional formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of the reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of the reconstituted, ready-to-use        nutritional formula.

In certain embodiments, the nutritional formula includes the followingcomponents (e.g., alone, or in combination) in the following weightranges, in grams per liter (g/L) of reconstituted, ready-to-usenutritional formula:

-   -   a) approximately 7 grams to approximately 9 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of the        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 2.8 grams of        alpha-lactalbumin enriched whey protein concentrate per L of the        reconstituted, ready-to-use nutritional formula;    -   c) approximately 22.0 grams to approximately 25.0 grams of        demineralized whey per L of the reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.75 grams to approximately 18.0 grams of        skimmed milk powder per L of the reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.06 grams to approximately 0.17 grams of        lactoferrin per L of the reconstituted, ready-to-use nutritional        formula;    -   f) approximately 34.0 grams to approximately 39.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of the        reconstituted, ready-to-use nutritional formula;    -   g) approximately 65 grams to approximately 70.0 grams of lactose        per L of the reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.0006 grams to approximately 0.001 grams of        lutein per L of the reconstituted, ready-to-use nutritional        formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.3 grams of        arachidonic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6.2 grams linoleic        acid per L of the reconstituted, ready-to-use nutritional        formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   m) approximately 2.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.05 grams of inositol per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.02 grams of Vitamin A per L of the reconstituted, ready-to-use        nutritional formula, approximately 0.005 grams to approximately        0.009 grams of niacin per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.006 grams of Vitamin D3 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.001 grams to approximately 0.005 grams of pantothenic acid per        L of the reconstituted, ready-to-use nutritional formula;        approximately 0.0005 grams to approximately 0.0015 grams of        Vitamin K1 per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.0015        grams of Vitamin B1 per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of the reconstituted, ready-to-use nutritional formula;        approximately 0.0001 grams to approximately 0.002 grams of folic        acid per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams of biotin per L of the reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams of Vitamin B12 per L of the        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.2 grams to approximately        0.5 grams of trisodium citrate dihydrate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.006 grams of dimagnesium        phosphate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00002 grams to approximately 0.00005        grams of sodium selenite per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.02 grams to        approximately 0.06 grams of iron (II) sulfate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.01 grams to approximately 0.03 grams of zinc sulfate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.004 grams of copper        sulfate per L of the reconstituted, ready-to-use nutritional        formula; and approximately 0.001 grams to approximately 0.0045        grams of manganese (II) sulfate per L of the reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of cytidine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.006 grams of        guanosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; and approximately 0.01 grams        to approximately 0.03 grams of uridine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of the reconstituted,        ready-to-use nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.03 grams to approximately        0.07 grams of taurine per L of the reconstituted, ready-to-use        nutritional formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of the reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of the reconstituted, ready-to-use        nutritional formula.

In certain embodiments, the nutritional formula includes approximately3.0 grams to approximately 10.0 grams of whey protein concentrate per Lof reconstituted, ready-to-use nutritional formula; approximately 2.0grams to approximately 3.0 grams of alpha-lactalbumin enriched wheyprotein concentrate per liter (L) of reconstituted, ready-to-usenutritional formula; demineralized whey; whey protein concentrate;skimmed milk powder; approximately 0.01 grams to approximately 0.2 gramsof lactoferrin per L of reconstituted, ready-to-use nutritional formula;approximately 35 grams to approximately 38 grams of a vegetable oilblend comprising an oleic acid-palmitic acid-oleic acid triglyceride, inwhich the vegetable oil blend includes approximately 4.25 grams toapproximately 5.25 grams of oleic acid-palmitic acid-oleic acidtriglyceride per L of reconstituted, ready-to-use nutritional formula(e.g., wherein the triglyceride is vegetable-derived); approximately 70grams to approximately 75 grams of lactose per L of reconstituted,ready-to-use nutritional formula; approximately 60 micrograms toapproximately 0.025 grams of lutein per L of reconstituted, ready-to-usenutritional formula; approximately 0.05 grams to approximately 0.3 gramsof docosahexanoic acid per L of reconstituted, ready-to-use nutritionalformula; approximately 0.05 grams to approximately 0.3 grams ofarachidonic acid per L of reconstituted, ready-to-use nutritionalformula; approximately 5.0 grams to approximately 6.0 grams linoleicacid per L of reconstituted, ready-to-use nutritional formula;approximately 0.3 grams to approximately 0.6 grams alpha-linolenic acidper L of reconstituted, ready-to-use nutritional formula; approximately2.5 grams to approximately 5.5 grams of galactooligosaccharides per L ofreconstituted, ready-to-use nutritional formula; approximately 0.1 gramsto approximately 0.5 grams of fructooligosaccharides per L ofreconstituted, ready-to-use nutritional formula; approximately 0.05grams to approximately 0.15 grams of Vitamin C per L of reconstituted,ready-to-use nutritional formula; approximately 0.001 grams toapproximately 0.05 grams of Vitamin E per L of reconstituted,ready-to-use nutritional formula; approximately 0.01 grams toapproximately 0.05 grams of inositol per L of reconstituted,ready-to-use nutritional formula; approximately 0.0005 grams toapproximately 0.02 grams of Vitamin A (e.g., approximately 0.005 gramsto 0.015 grams, 0.01 grams to 0.015 grams, 0.01 grams to 0.02 grams,etc.) per L of reconstituted, ready-to-use nutritional formula,approximately 0.005 grams to approximately 0.009 grams of niacin per Lof reconstituted, ready-to-use nutritional formula; approximately0.00001 grams to approximately 0.006 grams (e.g., approximately 10micrograms to approximately 20 micrograms, 0.005 grams to 0.006 grams,etc.) of Vitamin D3 per L of reconstituted, ready-to-use nutritionalformula; approximately 0.001 grams to approximately 0.005 grams ofpantothenic acid per L of reconstituted, ready-to-use nutritionalformula; approximately 0.0005 grams to approximately 0.0015 grams ofVitamin K1 per L of reconstituted, ready-to-use nutritional formula;approximately 0.0005 grams to approximately 0.0015 grams (e.g., 0.0004grams to 0.0006 grams, 0.0007 grams to 0.0013 grams, etc.) of Vitamin B1per L of reconstituted, ready-to-use nutritional formula; approximately0.00001 grams to approximately 0.001 grams (e.g., 0.0005 grams to 0.001grams, 0.00003 to 0.00005 grams, etc.) of Vitamin B2 per L ofreconstituted, ready-to-use nutritional formula; approximately 0.0001grams to approximately 0.0008 grams of Vitamin B6 per L ofreconstituted, ready-to-use nutritional formula; approximately 0.00001grams to approximately 0.002 grams (e.g., 0.00001 grams to 0.00003grams, 0.0005 to 0.0015 grams, etc.) of folic acid per L ofreconstituted, ready-to-use nutritional formula; approximately 0.00001grams to approximately 0.004 grams (e.g., 0.00001 grams to 0.00003grams, 0.002 to 0.004 grams, etc.) of biotin per L of reconstituted,ready-to-use nutritional formula; and approximately 0.000001 grams toapproximately 0.0005 grams (e.g., 0.000001 grams to 0.000003 grams,0.0001 to 0.0005 grams, etc.) of Vitamin B12 per L of reconstituted,ready-to-use nutritional formula; approximately 0.5 grams toapproximately 0.8 grams of dicalcium phosphate per L of reconstituted,ready-to-use nutritional formula; approximately 0.3 grams toapproximately 0.8 grams of calcium carbonate per L of reconstituted,ready-to-use nutritional formula; approximately 0.3 grams toapproximately 0.5 grams of potassium chloride per L of reconstituted,ready-to-use nutritional formula; approximately 0.00004 grams toapproximately 0.04 grams of potassium iodide per L of reconstituted,ready-to-use nutritional formula; approximately 0.4 grams toapproximately 0.7 grams potassium citrate per L of reconstituted,ready-to-use nutritional formula; approximately 0.3 grams toapproximately 0.5 grams of sodium citrate per L of reconstituted,ready-to-use nutritional formula; approximately 0.2 grams toapproximately 0.5 grams of trisodium citrate dihydrate per L ofreconstituted, ready-to-use nutritional formula; approximately 0.002grams to approximately 0.006 grams of dimagnesium phosphate trihydrateper L of reconstituted, ready-to-use nutritional formula; approximately0.2 grams to approximately 0.4 grams of magnesium chloride hexahydrateper L of reconstituted, ready-to-use nutritional formula; approximately0.00002 grams to approximately 0.00005 grams of sodium selenite per L ofreconstituted, ready-to-use nutritional formula; approximately 0.02grams to approximately 0.06 grams of iron (II) sulfate per L ofreconstituted, ready-to-use nutritional formula; approximately 0.01grams to approximately 0.03 grams of zinc sulfate monohydrate per L ofreconstituted, ready-to-use nutritional formula; approximately 0.001grams to approximately 0.004 grams of copper sulfate per L ofreconstituted, ready-to-use nutritional formula; and approximately 0.001grams to approximately 0.003 grams of manganese (II) sulfate monohydrateper L of reconstituted, ready-to-use nutritional formula; andapproximately 0.05 grams to approximately 0.1 grams of adenosine5′-monophosphate per L of reconstituted, ready-to-use nutritionalformula; approximately 0.01 grams to approximately 0.03 grams ofcytidine 5′-monophosphate per L of reconstituted, ready-to-usenutritional formula; approximately 0.001 grams to approximately 0.006grams of guanosine 5′-monophosphate per L of reconstituted, ready-to-usenutritional formula; and approximately 0.01 grams to approximately 0.03grams of uridine 5′-monophosphate per L of reconstituted, ready-to-usenutritional formula; approximately 0.1 grams to approximately 0.5 gramsof L-choline bitartrate per L of reconstituted, ready-to-use nutritionalformula; approximately 0.01 grams to approximately 0.03 grams ofL-carnitine per L of reconstituted, ready-to-use nutritional formula;approximately 0.0001 grams to approximately 0.0005 grams ofbeta-carotene per L of reconstituted, ready-to-use nutritional formula;approximately 0.03 grams to approximately 0.07 grams of taurine per L ofreconstituted, ready-to-use nutritional formula; approximately 0.3 gramsto approximately 0.5 grams of soya lecithin; and approximately 0.00001grams to approximately 0.00005 grams of maltodextrin per L ofreconstituted, ready-to-use nutritional formula per L of reconstituted,ready-to-use nutritional formula.

In certain embodiments, the nutritional formula includes approximately 3grams to approximately 10 grams whey protein concentrate that is notalpha-lactalbumin enriched, per L of the reconstituted, ready-to-usenutritional formula; approximately 2.5 grams to approximately 3.0 gramsof alpha-lactalbumin enriched whey protein concentrate per L of thereconstituted, ready-to-use nutritional formula; approximately 20.0grams to approximately 30.0 grams of demineralized whey per L of thereconstituted, ready-to-use nutritional formula; approximately 16.5grams to approximately 18.5 grams of skimmed milk powder per L of thereconstituted, ready-to-use nutritional formula; approximately 0.02grams to approximately 0.17 grams of lactoferrin per L of thereconstituted, ready-to-use nutritional formula; approximately 30.0grams to approximately 42.0 grams of a vegetable oil blend comprisingthe oleic acid-palmitic acid-oleic acid triglyceride; in whichapproximately 3.0 grams to approximately 7.0 grams of the vegetable oilblend is oleic acid-palmitic acid-oleic acid triglyceride per L of thereconstituted, ready-to-use nutritional formula; approximately 65 gramsto approximately 80 grams of lactose per L of the reconstituted,ready-to-use nutritional formula; approximately 0.00006 grams toapproximately 0.025 grams of lutein per L of the reconstituted,ready-to-use nutritional formula; approximately 0.05 grams toapproximately 0.09 grams of docosahexanoic acid per L of thereconstituted, ready-to-use nutritional formula; approximately 0.1 gramsto approximately 0.5 grams of arachidonic acid per L of thereconstituted, ready-to-use nutritional formula; approximately 5 gramsto approximately 6.2 grams linoleic acid per L of the reconstituted,ready-to-use nutritional formula; approximately 0.25 grams toapproximately 0.6 grams alpha-linolenic acid per L of the reconstituted,ready-to-use nutritional formula; approximately 2.0 grams toapproximately 5.0 grams of galactooligosaccharides per L of thereconstituted, ready-to-use nutritional formula; approximately 0.10grams to approximately 0.50 grams of fructooligosaccharides per L of thereconstituted, ready-to-use nutritional formula; approximately 0.05grams to approximately 0.15 grams of Vitamin C, approximately 0.001grams to approximately 0.05 grams of Vitamin E per L of thereconstituted, ready-to-use nutritional formula; approximately 0.01grams to approximately 0.05 grams of inositol per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0005grams to approximately 0.02 grams of Vitamin A per L of thereconstituted, ready-to-use nutritional formula, approximately 0.005grams to approximately 0.009 grams of niacin per L of the reconstituted,ready-to-use nutritional formula; approximately 0.00001 grams toapproximately 0.006 grams of Vitamin D3 per L of the reconstituted,ready-to-use nutritional formula; approximately 0.001 grams toapproximately 0.005 grams of pantothenic acid per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0005grams to approximately 0.0015 grams of Vitamin K1 per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0005grams to approximately 0.0015 grams of Vitamin B1 per L of thereconstituted, ready-to-use nutritional formula; approximately 0.00001grams to approximately 0.001 grams of Vitamin B2 per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0001grams to approximately 0.0008 grams of Vitamin B6 per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0001grams to approximately 0.002 grams of folic acid per L of thereconstituted, ready-to-use nutritional formula; approximately 0.00001grams to approximately 0.004 grams of biotin per L of the reconstituted,ready-to-use nutritional formula; and approximately 0.000001 grams toapproximately 0.0005 grams of Vitamin B12 per L of the reconstituted,ready-to-use nutritional formula; approximately 0.5 grams toapproximately 0.8 grams of dicalcium phosphate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.3 gramsto approximately 0.8 grams of calcium carbonate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.3 gramsto approximately 0.5 grams of potassium chloride per L of thereconstituted, ready-to-use nutritional formula; approximately 0.4 gramsto approximately 0.7 grams of tripotassium citrate monohydrate per L ofthe reconstituted, ready-to-use nutritional formula; approximately 0.3grams to approximately 0.5 grams of sodium citrate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.2 gramsto approximately 0.5 grams of trisodium citrate dihydrate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.002grams to approximately 0.006 grams of dimagnesium phosphate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.00002grams to approximately 0.00005 grams of sodium selenite per L of thereconstituted, ready-to-use nutritional formula; approximately 0.02grams to approximately 0.06 grams of iron (II) sulfate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.01grams to approximately 0.03 grams of zinc sulfate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.001grams to approximately 0.004 grams of copper sulfate per L of thereconstituted, ready-to-use nutritional formula; and approximately 0.001grams to approximately 0.0045 grams of manganese (II) sulfate per L ofthe reconstituted, ready-to-use nutritional formula; approximately 0.05grams to approximately 0.1 grams of adenosine 5′-monophosphate per L ofthe reconstituted, ready-to-use nutritional formula; approximately 0.01grams to approximately 0.03 grams of cytidine 5′-monophosphate per L ofthe reconstituted, ready-to-use nutritional formula; approximately 0.001grams to approximately 0.006 grams of guanosine 5′-monophosphate per Lof the reconstituted, ready-to-use nutritional formula; andapproximately 0.01 grams to approximately 0.03 grams of uridine5′-monophosphate per L of the reconstituted, ready-to-use nutritionalformula; approximately 0.1 grams to approximately 0.5 grams of L-cholinebitartrate per L of the reconstituted, ready-to-use nutritional formula;approximately 0.005 grams to approximately 0.03 grams of L-carnitine perL of the reconstituted, ready-to-use nutritional formula; approximately0.0001 grams to approximately 0.0007 grams of beta-carotene per L of thereconstituted, ready-to-use nutritional formula; approximately 0.03grams to approximately 0.07 grams of taurine per L of the reconstituted,ready-to-use nutritional formula; approximately 0.3 grams toapproximately 0.5 grams of soya lecithin per L of the reconstituted,ready-to-use nutritional formula; and approximately 0.00001 grams toapproximately 0.00005 grams of maltodextrin per L of the reconstituted,ready-to-use nutritional formula.

In certain embodiments, the present disclosure provides a nutritionalformula comprising:

-   -   a) alpha-lactalbumin enriched whey protein concentrate;    -   b) lactoferrin;    -   c) oleic acid-palmitic acid-oleic acid triglyceride, wherein        palmitic acid is at the SN-2 position of the glycerol backbone        of the triglyceride;    -   d) lactose;    -   e) lutein;    -   f) docosahexanoic acid;    -   g) arachidonic acid;    -   h) galactooligosaccharides; and    -   i) fructooligosaccharides.

In certain embodiments, the present disclosure provides a nutritionalformula comprising:

-   -   a) alpha-lactalbumin enriched whey protein concentrate;    -   b) lactoferrin;    -   c) oleic acid-palmitic acid-oleic acid triglyceride, wherein        palmitic acid is at the SN-2 position of the glycerol backbone        of the triglyceride;    -   d) lactose;    -   e) lutein;    -   f) docosahexanoic acid;    -   g) arachidonic acid;    -   h) galactooligosaccharides;    -   i) fructooligosaccharides.    -   j) vitamins;    -   k) minerals;    -   l) nucleotides;    -   m) soya lecithin;    -   n) maltodextrin;    -   o) beta-carotene; and    -   p) taurine.

In certain embodiments, the present disclosure provides a nutritionalformula comprising:

-   -   a) alpha-lactalbumin enriched whey protein concentrate;    -   b) lactoferrin;    -   c) oleic acid-palmitic acid-oleic acid triglyceride, wherein        palmitic acid is at the SN-2 position of the glycerol backbone        of the triglyceride;    -   d) lactose;    -   e) lutein;    -   f) docosahexanoic acid;    -   g) arachidonic acid;    -   h) galactooligosaccharides;    -   i) fructooligosaccharides.    -   j) vitamins;    -   k) minerals;    -   l) nucleotides;    -   m) soya lecithin;    -   n) beta-carotene; and    -   o) taurine.

In certain embodiments, the nutritional formula is provided in a powderform. In certain embodiments, the nutritional formula is provided in aliquid form.

The present disclosure also provides reconstituted formulationscomprising a powder form of the nutritional formula described herein,reconstituted with water (e.g., approximately 450 mL to approximately900 mL water) to yield a ready-to-feed liquid. In certain embodiments,the nutritional formulation is reconstituted with 450 mL or 500 mL waterto form approximately 0.5 L of reconstituted nutritional formulation. Incertain embodiments, the nutritional formulation is reconstituted with900 mL water to form approximately 1 L of reconstituted nutritionalformulation. In certain embodiments, the nutritional formulation isreconstituted with approximately 1 L water to form approximately 1.1 Lof reconstituted nutritional formulation.

Also provided herein are liquid concentrates of a nutritional formuladescribed herein, wherein the liquid concentrates can be diluted to forma ready-to-feed liquid formula.

Kits and Administration

Nutritional formulas described herein can be prepared by any methodknown in the art of nutritional formulations and manufacturing. In someembodiments, a preparatory method disclosed herein comprises combiningingredients of the nutritional formula into an aqueous slurry, includingprotein, carbohydrate, fat or lipid blends, prebiotics, minerals,lutein, beta-carotene, and/or combinations thereof, heating the aqueousslurry to approximately 140° F., and then homogenizing, pasteurizing,cooling, and spray drying the aqueous slurry. Other materials, includingvitamins, minerals, nucleotides, polyunsaturated fatty acids (e.g.,arachidonic acid and docosahexanoic acid), proteins (e.g., lactoferrin),and/or combinations thereof, may be added to the spray dried solution,followed by further processing and packaging.

In certain embodiments, such preparatory methods for preparing thenutritional formulas include a two-step process, as described above inthe section titled “Methods of Preparing Nutritional Formulas.” Thefirst step involves the addition of macroingredients, including protein(e.g., alpha-lactalbumin enriched whey protein concentrate, whey proteinconcentrate, skimmed milk powder, demineralized whey), carbohydrate(e.g., maltodextrin, lactose), prebiotics (e.g.,galactooligosaccharides, fructooligosaccharides), base mineral premix,fat or lipid (e.g., lecithin), lutein, beta-carotene, and/orcombinations thereof, into a base mixing tank containing water (e.g.,reverse osmosis processed water) and outfitted with a high speed mixer.In certain embodiments, the first step involves the addition ofmacroingredients, including protein (e.g., alpha-lactalbumin enrichedwhey protein concentrate, whey protein concentrate, skimmed milk powder,demineralized whey), carbohydrate (e.g., maltodextrin, lactose),prebiotics (e.g., galactooligosaccharides, fructrooligosaccharides),base mineral premix, fat or lipid (e.g., lecithin), lutein,beta-carotene, and/or combinations thereof, into a base mixing tankcontaining water (e.g., reverse osmosis processed water) and outfittedwith a high speed mixer. A vegetable oil blend (e.g., INFAT® fat blend,including OPO SN-2 oil) is then added into the base mixing tank andheated (e.g., heated to 140° F.). This forms an aqueous slurry. Theaqueous slurry is then purified. In certain embodiments, the aqueousslurry is first transferred into a two-stage homogenizer, followed bytransfer to a two-stage pasteurizer. Next, the slurry is dried. Incertain embodiments, hot filtered air (e.g., with a temperature ofapproximately 350° F. to approximately 400° F.) is used to spray dry themixture. Sifting is used to trap large particles, wherein these largertrapped particles are added back into the tall form spray drier toachieve complete drying. Once a low moisture level (e.g., a moisturelevel of approximately 2% or less) is achieved, the dried powder istransferred into a powder hopper for bagging into large nitrogen flushedbags (e.g., bags of 20-40 kg).

In some embodiments, the second stage of the process involves theaddition of the vitamin premix, trace minerals premix, and nucleotidespremix to one bag of 20-40 kg (e.g., a 25 kg bag), as a base. Thismixture is placed in a small mixer with lactoferrin (e.g., freeze-driedlactoferrin), along with polyunsaturated fatty acids (e.g., arachidonicacid and docosahexanoic acid), and then gently blended. A total ofapproximately thirty to forty (e.g., thirty-five) of each bag (e.g.,each 25 kg bag) that has undergone the above additions are combined in alarge paddle blender. Next, the powdered forms of the nutritionalformula are packaged and distributed. In certain embodiments, a screenmagnet, vertical filler, and case sealer are used to fill and sealindividual packets of the powder nutritional formula (e.g., powderpackets), wherein approximately one hundred (e.g., 96) powder packetscan be produced per minute. The completed product is placed intocontainers for distribution.

Also encompassed by the disclosure are kits (e.g., packages of powdernutritional formula). The kits provided may comprise a nutritionalformulation described herein and a container (e.g., a suitablecontainer), or reconstituted formulas described herein. Thus, in oneaspect, provided are kits including a container comprising a nutritionalformulation described herein. In certain embodiments, the kits areuseful for providing methods, uses, and uses in the manufacture of amedicament for nutrition (e.g., promoting postnatal development of thegastrointestinal tract, promoting development of an infant'sgastrointestinal tract, promoting proper gastrointestinal function(e.g., intestinal microbiota), promoting nutrient (e.g., calcium)absorption, promoting immune system development; and/or improving bonestrength, sleep (e.g., sleep patterns), decreased crying (duration,frequency), and/or decreased fussiness, etc) to a subject (e.g., aninfant). In certain embodiments, the kits are useful in a methoddescribed herein.

In certain embodiments, a kit described herein further includesinstructions, for example, preparing (e.g., reconstituting) the powderedformula, administering the formula to a subject (e.g., infant) for usingthe powder nutritional formula included in the kit. The nutritionalformula may be provided in convenient serving for administering(serving) to a subject. The kit may include a dehydrated nutritionalformula and a diluting agent (e.g., water). In certain embodiments, thediluting agent is water. The kit may include multiple dosage units. Forexample, the kit may include 1-100 packages (e.g., servings). In certainembodiments, a kit includes multiple servings (e.g., one or morepackages, wherein each package comprises approximately 1.0 g to 100 g, 1g to 5 g, 5 g to 10 g, 10 g to 25 g, 25 g to 50 g, or 50 g to 100 g, ofthe powdered nutritional formula described herein. In certainembodiments, a serving is the amount of powdered nutritional formuladescribed herein which produces the following amount of a reconstitutedformula per administration (e.g., feeding): for example, approximately0.1 L-0.25 L of the reconstituted formula, approximately 0.1 L-0.5 L ofthe reconstituted formula. In certain embodiments, a serving is theamount of powdered nutritional formula which produces the followingamount of a reconstituted formula per administration (e.g., feeding):approximately 0.01 L-0.025 L, 0.025 L-0.05 L, 0.05 L-0.1 L, 0.25 L-0.5L, 0.5 L-0.75 L, 0.6 L to 0.8 L, 0.6 L to 0.77 L, 0.5 L-1.0 L, 1.0L-1.25 L, of the reconstituted formula. In certain embodiments, the kitcomprises 1-100 servings, which comprises an administration of 0.5 L-1.0L or 0.6 L-0.77 L of the reconstituted formula per day.

In some embodiments, the kits described herein also include informationas required by a regulatory agency such as the U.S. Food and DrugAdministration (FDA). In certain embodiments, the kits includeinstructions on calculating a serving and/or providing nutrition to asubject. Also encompassed by the disclosure are devices (e.g., bottles)for administering to (e.g., feeding) a subject the nutritional formulaor reconstituted formula. The kits provided may comprise one or morepackages of the nutritional formula described herein, in powder orliquid form, and instructions, for example, preparing (e.g.,reconstituting with water) the powdered formula, or administering (e.g.,feeding) the formula to a subject (e.g., infant).

Methods of Preparing Nutritional Formulas

The present disclosure provides methods of preparing a nutritionalformula described herein. In certain embodiments, the nutritionalformula is prepared using a two-step process (e.g., as shown in FIGS.1A, 1B, and 2 ). In certain embodiments, the nutritional formula isprepared with a first step that involves the addition ofmacroingredients (e.g., protein, milk powder, saccharide (e.g.,lactose)), prebiotics, base mineral premix, and/or vitamins, into a basemixing tank containing processed water and outfitted with a high speedmixer. The vegetable oil blend (e.g., vegetable fat blend, includingphospholipids, omega fatty acids) are then added into the base mixingtank and heated (e.g., to approximately 140° F.). In certainembodiments, the slurry is then transferred into a homogenizer (e.g., atwo-stage homogenizer), followed by transfer to a pasteurizer (e.g.,two-stage pasteurizer). In certain embodiments, next, hot filtered air(e.g., with a temperature of approximately 350° F. to approximately 400°F.) is used to spray dry the mixture; followed by sifting to trap largerparticles, wherein these larger particles are added back into the spraydrier to achieve complete drying. In certain embodiments, when anappropriate moisture level (e.g., of approximately 3% or less) isachieved, the nutritional formula powder is transferred into a powderhopper for bagging. In certain embodiments, the second stage of theprocess used to prepare the nutritional formula involves the addition ofthe vitamin premix (e.g., with lutein), trace minerals premix,nucleotides premix, and specific protein (e.g., lactoferrin), to the dryblend base; processed, blended, poached; and then the nutritionalformula is stored. In certain embodiments, the nutritional formula isprepared as described in FIGS. 1A, 1B, and 2 ; and/or Example 1.

Methods of Administration and Feeding

The present disclosure provides methods of administering or providingnutrition to (e.g., feeding) a subject (e.g., newborn, infant) in needthereof. In certain embodiments, the method of providing nutrition to asubject comprises administering (e.g., feeding) a nutritional formuladescribed herein to a subject. In certain embodiments, the administerednutritional formula is a previously reconstituted ready-to-feed liquid.In certain embodiments, the method of providing nutrition to a subjectcomprises preparing (e.g., reconstituting) the nutritional formula inpowder form with water to form a ready-to-feed liquid. In certainembodiments, the methods of the disclosure include administering (e.g.,feeding) the subject with the reconstituted formula. In certainembodiments, the methods of the disclosure include administering (e.g.,feeding) the subject with approximately 0.1 L-0.25 L of thereconstituted formula per feeding, or approximately 0.1 L-0.5 L of thereconstituted formula per feeding. In certain embodiments, the methodsof the disclosure include administering (e.g., feeding) the subject with0.25 L-0.5 L, 0.5 L-0.75 L, 0.6 L to 0.8 L, 0.6 L to 0.77 L, 0.5 L-1.0L, 1.0 L-1.25 L, of the reconstituted formula per day. In certainembodiments, the methods of the disclosure include administering (e.g.,feeding) the subject with 0.5 L-1.0 L of the reconstituted formula perday. In certain embodiments, the methods of the disclosure includeadministering (e.g., feeding) the subject with 0.6 L-0.77 L of thereconstituted formula per day. In certain embodiments, the methodcomprises administering (e.g., feeding) the subject one to six servings(e.g., feedings) per day, or administering (e.g., feeding) the subjectfour to six servings (e.g., feedings) per day. In certain embodiments,the subject is a human (e.g., an infant). In certain embodiments, thesubject is not more than about two years of age. In certain embodiments,the subject is a newborn that is not more than about 4 weeks of age. Incertain embodiments, the subject is an infant from about 0 to about 4months of age, from about 4 to about 8 months of age, from about 8 toabout 12 months of age, from about 12 to about 16 months of age, fromabout 16 to about 18 months of age, from about 18 to about 24 months ofage, and from about 24 to about 30 months of age, from about 30 to about36 months of age, and preterm infants that are less than about 37 weeksgestational age. In certain embodiments, the subject is an infant notmore than about thirty-six (36) months of age, an infant not more thanabout thirty months of age, an infant not more than about two years ofage, an infant not more than about eighteen months of age, an infant notmore than about one year of age, an infant not more than about sixmonths of age, or a newborn. In certain embodiments, the subject is anewborn infant that is not more than about 4 weeks of age, an infantfrom about 0 to about 1 week of age, from about 1 to about 2 weeks ofage, from about 2 to about 3 weeks of age, and from about 3 to about 4weeks of age. In certain embodiments, the subject is a newborn infantthat is not more than about 10 days of age, not more than about 11 daysof age, not more than about 12 days of age, not more than about 13 daysof age, not more than about 14 days of age, not more than about 4 weeksof age, an infant from about 0 to about 1 week of age, from about 1 toabout 2 weeks of age, from about 2 to about 3 weeks of age, and fromabout 3 to about 4 weeks of age. In certain embodiments, the subject isa newborn infant that is an early-term infant of less than 37 weeks; afull-term infant of no less than 37 weeks; a late term infant of nogreater than 41 weeks; or a late term infant of no greater than 41weeks, 6 days. In certain embodiments, the subject is a newborn infantthat is a full-term infant of no less than 37 weeks; a late term infantof no greater than 41 weeks; or a late term infant of no greater than 41weeks, 6 days.

In certain embodiments, the method of providing nutrition oradministering (e.g., feeding) may be useful for providing nutrition aswell as methods, uses, and uses in the manufacture of a medicament forpromoting postnatal development of the gastrointestinal tract, forexample, promoting development of an infant's gastrointestinal tract,proper gastrointestinal function (e.g., intestinal microbiota),promoting nutrient (e.g., calcium) absorption, promoting immune systemdevelopment; and/or improving bone strength, sleep (e.g., sleeppatterns), decreased crying (duration, frequency), and/or decreasedfussiness, etc. In certain embodiments, the methods, uses, and uses inthe manufacture of a medicament for of providing nutrition may be usefulfor postnatal development of the gastrointestinal tract. In certainembodiments, the methods of providing nutrition may be useful forpromoting nutrient absorption. In certain embodiments, the methods ofproviding nutrition may be useful for immune system development.

In certain embodiments, the methods of the disclosure includeadministering to a subject an effective amount of a nutritional formuladescribed herein. In certain embodiments, the subject is a human. Incertain embodiments, the subject is a child. In certain embodiments, thesubject is an infant. In certain embodiments, the subject is an infantnot more than about thirty-six (36) months of age, an infant not morethan about thirty months of age, an infant not more than about two yearsof age, an infant not more than about eighteen months of age, an infantnot more than about one year of age, an infant not more than about sixmonths of age, or a newborn. In certain embodiments, the subject is anewborn. In certain embodiments, the subject is a toddler. In certainembodiments, the subject is an adult. In certain embodiments, thesubject is an adolescent.

In certain embodiments, provided are uses of the nutritional compositiondescribed herein, or a reconstituted form thereof, for providingnutrition as well as promoting postnatal development of thegastrointestinal tract, for example, promoting development of aninfant's gastrointestinal tract, proper gastrointestinal function (e.g.,intestinal microbiota), promoting nutrient (e.g., calcium) absorption,promoting immune system development; and/or improving bone strength,sleep (e.g., sleep patterns), decreased crying (duration, frequency),and/or decreased fussiness, in a subject. In certain embodiments,provided are the nutritional composition described herein, or areconstituted form thereof, for use in providing nutrition as well aspromoting postnatal development of the gastrointestinal tract, forexample, promoting development of an infant's gastrointestinal tract,proper gastrointestinal function (e.g., intestinal microbiota),promoting nutrient (e.g., calcium) absorption, promoting immune systemdevelopment; and/or improving bone strength, sleep (e.g., sleeppatterns), decreased crying (duration, frequency), and/or decreasedfussiness, in a subject.

EXEMPLARY EMBODIMENTS First Exemplary Set of Embodiments

Embodiment 1. A nutritional formula comprising:

-   -   a) alpha-lactalbumin enriched whey protein concentrate;    -   b) lactoferrin;    -   c) oleic acid-palmitic acid-oleic acid triglyceride, wherein        palmitic acid is at the SN-2 position of the glycerol backbone        of the triglyceride;    -   d) lactose;    -   e) lutein;    -   f) docosahexanoic acid;    -   g) arachidonic acid;    -   h) galactooligosaccharides; and    -   i) fructooligosaccharides.        Embodiment 2. The nutritional formula of embodiment 1 further        comprising linoleic acid.        Embodiment 3. The nutritional formula of any one of embodiments        1-2 further comprising alpha-linolenic acid.        Embodiment 4. The nutritional formula of any one of embodiments        1-3 further comprising vitamins, minerals, nucleotides, or a        combination thereof.        Embodiment 5. The nutritional formula of any one of embodiments        1-4 further comprising L-choline bitartrate, L-carnitine, or a        combination thereof.        Embodiment 6. The nutritional formula of any one of embodiments        1-5 further comprising soya lecithin.        Embodiment 7. The nutritional formula of any one of embodiments        1-6 further comprising beta-carotene, taurine, or a combination        thereof.        Embodiment 8. The nutritional formula of any one of embodiments        4-7, wherein the vitamins comprise Vitamin C, Vitamin E,        inositol, Vitamin A, niacin, Vitamin D3, pantothenic acid,        Vitamin K1, Vitamin B1, Vitamin B2, Vitamin B6, folic acid,        biotin, Vitamin B12, or a combination thereof.        Embodiment 9. The nutritional formula of any one of embodiments        4-8, wherein the minerals comprise calcium, potassium, sodium,        magnesium, iron, zinc, manganese, copper, iodine, selenium,        chloride, and forms thereof.        Embodiment 10. The nutritional formula of any one of embodiments        4-9, wherein the minerals comprise calcium phosphate, calcium        carbonate, potassium chloride, potassium citrate, potassium        iodide, sodium citrate, sodium selenite, magnesium phosphate,        magnesium chloride, iron (II) sulfate, zinc sulfate monohydrate,        copper sulfate, manganese (II) sulfate monohydrate, or a        combination thereof.        Embodiment 11. The nutritional formula of any one of embodiments        4-10, wherein the nucleotides comprise adenosine        5′-monophosphate, cytidine 5′-monophosphate, guanosine        5′-monophosphate, uridine 5′-monophosphate, or a combination        thereof.        Embodiment 12. The nutritional formula of any one of embodiments        4-11, wherein the nucleotides comprise adenosine        5′-monophosphate, cytidine 5′-monophosphate, guanosine        5′-monophosphate, and uridine 5′-monophosphate.        Embodiment 13. The nutritional formula of any one of embodiments        1-12, wherein the nutritional formula comprises approximately        0.5 grams to approximately 4.2 grams of alpha-lactalbumin        enriched whey protein concentrate per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 14. The nutritional formula of any one of embodiments        1-13, wherein the nutritional formula comprises approximately        0.02 grams to approximately 1.0 grams of lactoferrin per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 15. The nutritional formula of embodiment 14, wherein        the nutritional formula comprises approximately 0.02 grams to        approximately 0.135 grams of lactoferrin per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 16. The nutritional formula of any one of embodiments        1-15, wherein the nutritional formula comprises approximately        1.0 grams to approximately 14.0 grams of the oleic acid-palmitic        acid-oleic acid triglyceride per L of reconstituted,        ready-to-use nutritional formula, wherein the palmitic acid is        at the SN-2 position of a glycerol backbone of the triglyceride.        Embodiment 17. The nutritional formula of embodiment 16, wherein        the nutritional formula comprises approximately 2.0 grams to        approximately 5.0 grams of the oleic acid-palmitic acid-oleic        acid triglyceride per L of reconstituted, ready-to-use        nutritional formula.        Embodiment 18. The nutritional formula of any one of embodiments        1-17, wherein the nutritional formula comprises approximately 60        micrograms to approximately 0.05 grams of lutein per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 19. The nutritional formula of embodiment 18, wherein        the nutritional formula comprises approximately 0.015 grams to        approximately 0.025 grams of lutein per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 20. The nutritional formula of embodiment 18, wherein        the nutritional formula comprises approximately 60 micrograms to        approximately 100 micrograms of lutein per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 21. The nutritional formula of embodiment 18, wherein        the nutritional formula comprises a lutein to DHA ratio of        approximately 1.0 to 1.0.        Embodiment 22. The nutritional formula of any one of embodiments        1-21, wherein the nutritional formula comprises approximately        0.001 grams to approximately 0.1 grams of docosahexanoic acid        per L of reconstituted, ready-to-use nutritional formula.        Embodiment 23. The nutritional formula of embodiment 22, wherein        the nutritional formula comprises approximately 0.1 grams to        approximately 1.0 grams of arachidonic acid per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 24. The nutritional formula of embodiment 22 or 23,        wherein the nutritional formula comprises approximately 0.05        grams to approximately 0.09 grams of docosahexanoic acid per L        of reconstituted, ready-to-use nutritional formula.        Embodiment 25. The nutritional formula of any one of embodiments        1-24, wherein the docosahexanoic acid is from Crypthecodinium        cohnii oil, Schizochytrium Sp. oil, or fish oil.        Embodiment 26. The nutritional formula of any one of embodiments        1-25, wherein the arachidonic acid is from Mortierella alpina        oil.        Embodiment 27. The nutritional formula of any one of embodiments        1-26, wherein the oleic acid-palmitic acid-oleic acid        triglyceride is approximately 30% to 50% of a vegetable oil        blend.        Embodiment 28. The nutritional formula of any one of embodiments        1-27, wherein the nutritional formula comprises approximately        1.0 grams to approximately 4.1 grams of galactooligosaccharides        per L of reconstituted, ready-to-use nutritional formula.        Embodiment 29. The nutritional formula of any one of embodiments        1-28, wherein the nutritional formula comprises approximately        0.1 grams to approximately 0.5 grams of fructooligosaccharides        per L of reconstituted, ready-to-use nutritional formula.        Embodiment 30. The nutritional formula of any one of embodiments        1-29, wherein the nutritional formula comprises approximately        2.5 grams to approximately 3.0 grams of alpha-lactalbumin        enriched whey protein concentrate per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 31. The nutritional formula of any one of embodiments        1-30, wherein the nutritional formula comprises approximately        2.6 grams to approximately 2.9 grams of alpha-lactalbumin        enriched whey protein concentrate per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 32. The nutritional formula of any one of embodiments        1-31, wherein the nutritional formula comprises approximately        0.5 grams to approximately 1.2 grams of alpha-lactalbumin per        100 grams of nutritional formula in powder form.        Embodiment 33. The nutritional formula of any one of embodiments        1-32, wherein the nutritional formula comprises approximately 35        grams to approximately 80 grams of lactose per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 34. The nutritional formula of any one of embodiments        1-33, wherein the nutritional formula comprises at most 85 grams        of lactose per L of reconstituted, ready-to-use nutritional        formula.        Embodiment 35. The nutritional formula of any one of embodiments        1-34, wherein the nutritional formula comprises approximately        5.3 grams to approximately 6.3 grams of linoleic acid per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 36. The nutritional formula of any one of embodiments        1-35, wherein the nutritional formula comprises approximately        5.3 grams to approximately 6.0 grams of linoleic acid per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 37. The nutritional formula of any one of embodiments        1-36, wherein the nutritional formula comprises approximately        0.25 grams to approximately 0.75 grams of alpha-linolenic acid        per L of reconstituted, ready-to-use nutritional formula.        Embodiment 38. The nutritional formula of any one of embodiments        1-37, wherein the nutritional formula comprises approximately        2.2 grams to approximately 5.5 grams of prebiotics per L of        reconstituted, ready-to-use nutritional formula, wherein the        prebiotics comprise galactooligosaccharides,        fructooligosaccharides, or a combination thereof.        Embodiment 39. The nutritional formula of any one of embodiments        1-37, wherein the nutritional formula comprises approximately        2.5 grams to approximately 5.5 grams of prebiotics per L of        reconstituted, ready-to-use nutritional formula, wherein the        prebiotics comprise galactooligosaccharides,        fructooligosaccharides, or a combination thereof.        Embodiment 40. The nutritional formula of any one of embodiments        1-39, wherein the nutritional formula comprises approximately        3.0 grams to approximately 5.0 grams of prebiotics per L of        reconstituted, ready-to-use nutritional formula, wherein the        prebiotics comprise galactooligosaccharides,        fructooligosaccharides, or a combination thereof.        Embodiment 41. The nutritional formula of any one of embodiments        1-38, wherein the nutritional formula comprises approximately        2.2 grams to approximately 4.5 grams of prebiotics per L of        reconstituted, ready-to-use nutritional formula, wherein the        prebiotics comprise galactooligosaccharides,        fructooligosaccharides, or a combination thereof.        Embodiment 42. The nutritional formula of any one of embodiments        1-41, wherein the nutritional formula comprises approximately        3.5 grams to approximately 4.5 grams of galactooligosaccharides        per L of reconstituted, ready-to-use nutritional formula.        Embodiment 43. The nutritional formula of any one of embodiments        1-41, wherein the nutritional formula comprises approximately        2.0 grams to approximately 4.2 grams of galactooligosaccharides        per L of reconstituted, ready-to-use nutritional formula.        Embodiment 44. The nutritional formula of any one of embodiments        1-43, wherein the nutritional formula comprises approximately        0.1 grams to approximately 0.3 grams of fructooligosaccharides        per L of reconstituted, ready-to-use nutritional formula.        Embodiment 45. The nutritional formula of any one of embodiments        1-43, wherein the nutritional formula comprises approximately        0.2 grams to approximately 0.42 grams of fructooligosaccharides        per L of reconstituted, ready-to-use nutritional formula.        Embodiment 46. The nutritional formula of any one of embodiments        1-45 further comprising at least approximately 0.00001 grams of        maltodextrin.        Embodiment 47. A nutritional formula comprising:    -   a) alpha-lactalbumin enriched whey protein concentrate;    -   b) lactoferrin;    -   c) oleic acid-palmitic acid-oleic acid triglyceride, wherein        palmitic acid is at the SN-2 position of the glycerol backbone        of the triglyceride;    -   d) lactose;    -   e) lutein;    -   f) docosahexanoic acid;    -   g) arachidonic acid;    -   h) galactooligosaccharides; and    -   i) fructooligosaccharides; and a powder form thereof.        Embodiment 48. The nutritional formula of any one of embodiments        1-47 further comprising demineralized whey.        Embodiment 49. The nutritional formula of any one of embodiments        1-48, wherein the oleic acid-palmitic acid-oleic acid        triglyceride is vegetable-derived.        Embodiment 50. The nutritional formula of any one of embodiments        1-49, further comprising whey protein concentrate that is not        alpha-lactalbumin enriched.        Embodiment 51. The nutritional formula of any one of embodiments        1-50 further comprising skimmed milk powder.        Embodiment 52. The nutritional formula of any one of embodiments        1-51 comprising the following weight ranges, in grams per liter        (g/L) of reconstituted, ready-to-use nutritional formula:    -   a) approximately 3 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 3.0 grams of        alpha-lactalbumin enriched whey protein concentrate per L of        reconstituted, ready-to-use nutritional formula;    -   c) approximately 20.0 grams to approximately 30.0 grams of        demineralized whey per L of reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.5 grams to approximately 18.5 grams of        skimmed milk powder per L of reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.02 grams to approximately 0.10 grams of        lactoferrin per L of reconstituted, ready-to-use nutritional        formula;    -   f) approximately 30.0 grams to approximately 42.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of        reconstituted, ready-to-use nutritional formula;    -   g) approximately 70 grams to approximately 80 grams of lactose        per L of reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.00006 grams to approximately 0.025 grams of        lutein per L of reconstituted, ready-to-use nutritional formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.5 grams of        arachidonic acid per L of reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6 grams linoleic acid        per L of reconstituted, ready-to-use nutritional formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of reconstituted, ready-to-use        nutritional formula;    -   m) approximately 3.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of reconstituted, ready-to-use nutritional        formula; approximately 0.01 grams to approximately 0.05 grams of        inositol per L of reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.02 grams        of Vitamin A per L of reconstituted, ready-to-use nutritional        formula, approximately 0.005 grams to approximately 0.009 grams        of niacin per L of reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.006        grams of Vitamin D3 per L of reconstituted, ready-to-use        nutritional formula; approximately 0.001 grams to approximately        0.005 grams of pantothenic acid per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0005 grams to        approximately 0.0015 grams of Vitamin K1 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0005 grams to        approximately 0.0015 grams of Vitamin B1 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0001 grams to        approximately 0.0008 grams of Vitamin B6 per L of reconstituted,        ready-to-use nutritional formula; approximately 0.0001 grams to        approximately 0.002 grams of folic acid per L of reconstituted,        ready-to-use nutritional formula; approximately 0.00001 grams to        approximately 0.004 grams of biotin per L of reconstituted,        ready-to-use nutritional formula; and approximately 0.000001        grams to approximately 0.0005 grams of Vitamin B12 per L of        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.2 grams to approximately 0.5 grams of        trisodium citrate dihydrate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.002 grams to approximately        0.006 grams of dimagnesium phosphate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.00002 grams to        approximately 0.00005 grams of sodium selenite per L of        reconstituted, ready-to-use nutritional formula; approximately        0.02 grams to approximately 0.06 grams of iron (II) sulfate per        L of reconstituted, ready-to-use nutritional formula;        approximately 0.01 grams to approximately 0.03 grams of zinc        sulfate per L of reconstituted, ready-to-use nutritional        formula; approximately 0.001 grams to approximately 0.004 grams        of copper sulfate per L of reconstituted, ready-to-use        nutritional formula; and approximately 0.001 grams to        approximately 0.003 grams of manganese (II) sulfate per L of        reconstituted, ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.03 grams of cytidine 5′-monophosphate per L of reconstituted,        ready-to-use nutritional formula; approximately 0.001 grams to        approximately 0.006 grams of guanosine 5′-monophosphate per L of        reconstituted, ready-to-use nutritional formula; and        approximately 0.01 grams to approximately 0.03 grams of uridine        5′-monophosphate per L of reconstituted, ready-to-use        nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of reconstituted, ready-to-use        nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of reconstituted, ready-to-use nutritional        formula; approximately 0.03 grams to approximately 0.07 grams of        taurine per L of reconstituted, ready-to-use nutritional        formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of reconstituted, ready-to-use nutritional        formula.        Embodiment 53. The nutritional formula of any one of embodiments        1-51 comprising the following weight ranges, in grams per liter        (g/L) of reconstituted, ready-to-use nutritional formula:    -   a) approximately 3 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of the        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 3.0 grams of        alpha-lactalbumin enriched whey protein concentrate per L of the        reconstituted, ready-to-use nutritional formula;    -   c) approximately 20.0 grams to approximately 30.0 grams of        demineralized whey per L of the reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.5 grams to approximately 18.5 grams of        skimmed milk powder per L of the reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.02 grams to approximately 0.17 grams of        lactoferrin per L of the reconstituted, ready-to-use nutritional        formula;    -   f) approximately 30.0 grams to approximately 42.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of the        reconstituted, ready-to-use nutritional formula;    -   g) approximately 65 grams to approximately 80 grams of lactose        per L of the reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.00006 grams to approximately 0.025 grams of        lutein per L of the reconstituted, ready-to-use nutritional        formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.5 grams of        arachidonic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6.2 grams linoleic        acid per L of the reconstituted, ready-to-use nutritional        formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   m) approximately 2.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.05 grams of inositol per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.02 grams of Vitamin A per L of the reconstituted, ready-to-use        nutritional formula, approximately 0.005 grams to approximately        0.009 grams of niacin per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.006 grams of Vitamin D3 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.001 grams to approximately 0.005 grams of pantothenic acid per        L of the reconstituted, ready-to-use nutritional formula;        approximately 0.0005 grams to approximately 0.0015 grams of        Vitamin K1 per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.0015        grams of Vitamin B1 per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of the reconstituted, ready-to-use nutritional formula;        approximately 0.0001 grams to approximately 0.002 grams of folic        acid per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams of biotin per L of the reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams of Vitamin B12 per L of the        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.2 grams to approximately        0.5 grams of trisodium citrate dihydrate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.006 grams of dimagnesium        phosphate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00002 grams to approximately 0.00005        grams of sodium selenite per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.02 grams to        approximately 0.06 grams of iron (II) sulfate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.01 grams to approximately 0.03 grams of zinc sulfate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.004 grams of copper        sulfate per L of the reconstituted, ready-to-use nutritional        formula; and approximately 0.001 grams to approximately 0.0045        grams of manganese (II) sulfate per L of the reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of cytidine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.006 grams of        guanosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; and approximately 0.01 grams        to approximately 0.03 grams of uridine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of the reconstituted,        ready-to-use nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.03 grams to approximately        0.07 grams of taurine per L of the reconstituted, ready-to-use        nutritional formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of the reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of the reconstituted, ready-to-use        nutritional formula.        Embodiment 54. The nutritional formula of any one of embodiments        1-51 comprising the following weight ranges, in grams per liter        (g/L) of reconstituted, ready-to-use nutritional formula:    -   a) approximately 6 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of the        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 2.9 grams of        alpha-lactalbumin enriched whey protein concentrate per L of the        reconstituted, ready-to-use nutritional formula;    -   c) approximately 22.0 grams to approximately 26.0 grams of        demineralized whey per L of the reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.5 grams to approximately 18.0 grams of        skimmed milk powder per L of the reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.05 grams to approximately 0.17 grams of        lactoferrin per L of the reconstituted, ready-to-use nutritional        formula;    -   f) approximately 33.0 grams to approximately 42.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of the        reconstituted, ready-to-use nutritional formula;    -   g) approximately 65 grams to approximately 98.0 grams of lactose        per L of the reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.0005 grams to approximately 0.003 grams of        lutein per L of the reconstituted, ready-to-use nutritional        formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.3 grams of        arachidonic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6.2 grams linoleic        acid per L of the reconstituted, ready-to-use nutritional        formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   m) approximately 2.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.05 grams of inositol per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.02 grams of Vitamin A per L of the reconstituted, ready-to-use        nutritional formula, approximately 0.005 grams to approximately        0.009 grams of niacin per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.006 grams of Vitamin D3 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.001 grams to approximately 0.005 grams of pantothenic acid per        L of the reconstituted, ready-to-use nutritional formula;        approximately 0.0005 grams to approximately 0.0015 grams of        Vitamin K1 per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.0015        grams of Vitamin B1 per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of the reconstituted, ready-to-use nutritional formula;        approximately 0.0001 grams to approximately 0.002 grams of folic        acid per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams of biotin per L of the reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams of Vitamin B12 per L of the        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.2 grams to approximately        0.5 grams of trisodium citrate dihydrate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.006 grams of dimagnesium        phosphate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00002 grams to approximately 0.00005        grams of sodium selenite per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.02 grams to        approximately 0.06 grams of iron (II) sulfate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.01 grams to approximately 0.03 grams of zinc sulfate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.004 grams of copper        sulfate per L of the reconstituted, ready-to-use nutritional        formula; and approximately 0.001 grams to approximately 0.0045        grams of manganese (II) sulfate per L of the reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of cytidine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.006 grams of        guanosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; and approximately 0.01 grams        to approximately 0.03 grams of uridine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of the reconstituted,        ready-to-use nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.03 grams to approximately        0.07 grams of taurine per L of the reconstituted, ready-to-use        nutritional formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of the reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of the reconstituted, ready-to-use        nutritional formula.        Embodiment 55. The nutritional formula of any one of embodiments        1-51 comprising the following weight ranges, in grams per liter        (g/L) of reconstituted, ready-to-use nutritional formula:    -   a) approximately 7 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of the        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.6 grams to approximately 2.9 grams of        alpha-lactalbumin enriched whey protein concentrate per L of the        reconstituted, ready-to-use nutritional formula;    -   c) approximately 23.0 grams to approximately 26.0 grams of        demineralized whey per L of the reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.75 grams to approximately 18.0 grams of        skimmed milk powder per L of the reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.06 grams to approximately 0.17 grams of        lactoferrin per L of the reconstituted, ready-to-use nutritional        formula;    -   f) approximately 34.0 grams to approximately 40.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of the        reconstituted, ready-to-use nutritional formula;    -   g) approximately 65 grams to approximately 70.0 grams of lactose        per L of the reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.0006 grams to approximately 0.003 grams of        lutein per L of the reconstituted, ready-to-use nutritional        formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.3 grams of        arachidonic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6.2 grams linoleic        acid per L of the reconstituted, ready-to-use nutritional        formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   m) approximately 2.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.05 grams of inositol per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.02 grams of Vitamin A per L of the reconstituted, ready-to-use        nutritional formula, approximately 0.005 grams to approximately        0.009 grams of niacin per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.006 grams of Vitamin D3 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.001 grams to approximately 0.005 grams of pantothenic acid per        L of the reconstituted, ready-to-use nutritional formula;        approximately 0.0005 grams to approximately 0.0015 grams of        Vitamin K1 per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.0015        grams of Vitamin B1 per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of the reconstituted, ready-to-use nutritional formula;        approximately 0.0001 grams to approximately 0.002 grams of folic        acid per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams of biotin per L of the reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams of Vitamin B12 per L of the        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.2 grams to approximately        0.5 grams of trisodium citrate dihydrate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.006 grams of dimagnesium        phosphate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00002 grams to approximately 0.00005        grams of sodium selenite per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.02 grams to        approximately 0.06 grams of iron (II) sulfate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.01 grams to approximately 0.03 grams of zinc sulfate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.004 grams of copper        sulfate per L of the reconstituted, ready-to-use nutritional        formula; and approximately 0.001 grams to approximately 0.0045        grams of manganese (II) sulfate per L of the reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of cytidine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.006 grams of        guanosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; and approximately 0.01 grams        to approximately 0.03 grams of uridine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of the reconstituted,        ready-to-use nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.03 grams to approximately        0.07 grams of taurine per L of the reconstituted, ready-to-use        nutritional formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of the reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of the reconstituted, ready-to-use        nutritional formula.        Embodiment 56. The nutritional formula of any one of embodiments        1-51 comprising the following weight ranges, in grams per liter        (g/L) of reconstituted, ready-to-use nutritional formula:    -   a) approximately 7 grams to approximately 9 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of the        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 2.8 grams of        alpha-lactalbumin enriched whey protein concentrate per L of the        reconstituted, ready-to-use nutritional formula;    -   c) approximately 22.0 grams to approximately 25.0 grams of        demineralized whey per L of the reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.75 grams to approximately 18.0 grams of        skimmed milk powder per L of the reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.06 grams to approximately 0.17 grams of        lactoferrin per L of the reconstituted, ready-to-use nutritional        formula;    -   f) approximately 34.0 grams to approximately 39.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of the        reconstituted, ready-to-use nutritional formula;    -   g) approximately 65 grams to approximately 70.0 grams of lactose        per L of the reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.0006 grams to approximately 0.001 grams of        lutein per L of the reconstituted, ready-to-use nutritional        formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.3 grams of        arachidonic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6.2 grams linoleic        acid per L of the reconstituted, ready-to-use nutritional        formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   m) approximately 2.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.05 grams of inositol per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.02 grams of Vitamin A per L of the reconstituted, ready-to-use        nutritional formula, approximately 0.005 grams to approximately        0.009 grams of niacin per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.006 grams of Vitamin D3 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.001 grams to approximately 0.005 grams of pantothenic acid per        L of the reconstituted, ready-to-use nutritional formula;        approximately 0.0005 grams to approximately 0.0015 grams of        Vitamin K1 per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.0015        grams of Vitamin B1 per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of the reconstituted, ready-to-use nutritional formula;        approximately 0.0001 grams to approximately 0.002 grams of folic        acid per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams of biotin per L of the reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams of Vitamin B12 per L of the        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.2 grams to approximately        0.5 grams of trisodium citrate dihydrate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.006 grams of dimagnesium        phosphate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00002 grams to approximately 0.00005        grams of sodium selenite per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.02 grams to        approximately 0.06 grams of iron (II) sulfate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.01 grams to approximately 0.03 grams of zinc sulfate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.004 grams of copper        sulfate per L of the reconstituted, ready-to-use nutritional        formula; and approximately 0.001 grams to approximately 0.0045        grams of manganese (II) sulfate per L of the reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of cytidine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.006 grams of        guanosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; and approximately 0.01 grams        to approximately 0.03 grams of uridine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of the reconstituted,        ready-to-use nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.03 grams to approximately        0.07 grams of taurine per L of the reconstituted, ready-to-use        nutritional formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of the reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of the reconstituted, ready-to-use        nutritional formula.        Embodiment 57. The nutritional formula of any one of embodiments        1-56, further comprising water to form a reconstituted,        ready-to-use nutritional formula.        Embodiment 58. The nutritional formula of embodiment 57, wherein        the water comprises approximately 450 mL to approximately 900 mL        water.        Embodiment 59. A method of providing nutrition to a subject,        wherein the method comprises: administering the nutritional        formula of any one of embodiments 1-56 or administering the        reconstituted formula of embodiment 57 or 58 to the subject.        Embodiment 60. A method of providing nutrition to a subject,        wherein the method comprises feeding the subject with the        nutritional formula of any one of embodiments 1-56 or feeding        the subject with the reconstituted formula of embodiment 57 or        58.        Embodiment 61. A method of providing nutrition to a subject,        wherein the method comprises reconstituting the formula of any        one of embodiments 1-56 with water to form a ready-to-feed        liquid.        Embodiment 62. The method of any one of embodiments 59-61        wherein the administering comprises administering to the subject        approximately 0.1 L-0.25 L of the reconstituted formula per        feeding.        Embodiment 63. The method of any one of embodiments 59-61        wherein the administering comprises administering to the subject        0.5 L-1.0 L of the reconstituted formula per day.        Embodiment 64. The method of any one of embodiments 59-61 or 63        wherein the administering comprises administering to the subject        0.6 L-0.77 L of the reconstituted formula per day.        Embodiment 65. The method of any one of embodiments 59-64        wherein the administering comprises administering to the subject        one to six feedings per day.        Embodiment 66. The method of any one of embodiments 59-65        wherein the administering comprises administering to the subject        four to six feedings per day.        Embodiment 67. The method of any one of embodiments 59-66,        wherein the subject is human.        Embodiment 68. The method of any one of embodiments 59-67,        wherein the subject is not more than about two years of age.        Embodiment 69. The method of any one of embodiments 59-68,        wherein the subject is a newborn that is not more than about 4        weeks of age.        Embodiment 70. The method of any one of embodiments 59-69,        wherein the subject is a newborn that is not more than about 14        days of age.        Embodiment 71. The method of any one of embodiments 59-70,        wherein the method promotes postnatal development of the        gastrointestinal tract, promotes proper gastrointestinal        function, promotes nutrient absorption, and/or promotes proper        immune system development.        Embodiment 72. Use of a nutritional formula of any one of        embodiments 1-56, or a reconstituted form thereof, for providing        nutrition, promoting postnatal development of the        gastrointestinal tract, promoting proper gastrointestinal        function, promoting nutrient absorption, and/or promoting proper        immune system development to a subject.        Embodiment 73. Use of a nutritional formula of any one of        embodiments 1-56, or a reconstituted form thereof, the        manufacture of a medicament for providing nutrition, promoting        postnatal development of the gastrointestinal tract, promoting        proper gastrointestinal function, promoting nutrient absorption,        and/or promoting proper immune system development.        Embodiment 74. A kit comprising:    -   i. one or more packages of the nutritional formula of any one of        embodiments 1-56, in powder form,    -   ii. reconstituting the nutritional formula by adding water; and    -   iii. instructions for administering the nutritional formula to a        subject.        Embodiment 75. The kit of embodiment 74, comprising the        nutritional formula of any one of embodiments 1-56 and a        diluting agent.

Second Exemplary Set of Embodiments

Embodiment 1. A nutritional formula comprising:

-   -   a) alpha-lactalbumin enriched whey protein concentrate;    -   b) lactoferrin;    -   c) oleic acid-palmitic acid-oleic acid triglyceride, wherein        palmitic acid is at the SN-2 position of the glycerol backbone        of the triglyceride;    -   d) lactose;    -   e) lutein;    -   f) docosahexanoic acid;    -   g) arachidonic acid;    -   h) galactooligosaccharides; and    -   i) fructooligosaccharides.        Embodiment 2. The nutritional formula of embodiment 1 further        comprising linoleic acid.        Embodiment 3. The nutritional formula of embodiment 1 further        comprising alpha-linolenic acid.        Embodiment 4. The nutritional formula of embodiment 1 further        comprising vitamins, minerals, nucleotides, or a combination        thereof.        Embodiment 5. The nutritional formula of embodiment 1 further        comprising L-choline bitartrate, L-carnitine, or a combination        thereof.        Embodiment 6. The nutritional formula of embodiment 1 further        comprising soya lecithin.        Embodiment 7. The nutritional formula of embodiment 1 further        comprising beta-carotene, taurine, or a combination thereof.        Embodiment 8. The nutritional formula of embodiment 4, wherein        the nucleotides comprise adenosine 5′-monophosphate, cytidine        5′-monophosphate, guanosine 5′-monophosphate, uridine        5′-monophosphate, or a combination thereof.        Embodiment 9. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 0.5 grams to        approximately 4.2 grams of alpha-lactalbumin enriched whey        protein concentrate per L of reconstituted, ready-to-use        nutritional formula.        Embodiment 10. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 0.02 grams to        approximately 1.0 grams of lactoferrin per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 11. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 1.0 grams to        approximately 14.0 grams of the oleic acid-palmitic acid-oleic        acid triglyceride per L of reconstituted, ready-to-use        nutritional formula.        Embodiment 12. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 60 micrograms to        approximately 0.05 grams of lutein per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 13. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 0.001 grams to        approximately 0.1 grams of docosahexanoic acid per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 14. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 0.1 grams to        approximately 1.0 grams of arachidonic acid per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 15. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 1.0 grams to        approximately 4.1 grams of galactooligosaccharides per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 16. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 0.1 grams to        approximately 0.5 grams of fructooligosaccharides per L of        reconstituted, ready-to-use nutritional formula.        Embodiment 17. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 2.5 grams to        approximately 5.5 grams of prebiotics per L of reconstituted,        ready-to-use nutritional formula, wherein the prebiotics        comprise galactooligosaccharides, fructooligosaccharides, or a        combination thereof.        Embodiment 18. The nutritional formula of embodiment 1 wherein        the nutritional formula comprises approximately 35 grams to        approximately 80 grams of lactose per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 19. The nutritional formula of embodiment 1, wherein        the nutritional formula comprises approximately 5.3 grams to        approximately 6.3 grams of linoleic acid per L of reconstituted,        ready-to-use nutritional formula.        Embodiment 20. The nutritional formula of embodiment 1, in a        powder form.        Embodiment 21. The nutritional formula of embodiment 1        comprising the following weight ranges, in grams per liter (g/L)        of reconstituted, ready-to-use nutritional formula:    -   a) approximately 3 grams to approximately 10 grams whey protein        concentrate that is not alpha-lactalbumin enriched, per L of the        reconstituted, ready-to-use nutritional formula;    -   b) approximately 2.5 grams to approximately 3.0 grams of        alpha-lactalbumin enriched whey protein concentrate per L of the        reconstituted, ready-to-use nutritional formula;    -   c) approximately 20.0 grams to approximately 30.0 grams of        demineralized whey per L of the reconstituted, ready-to-use        nutritional formula;    -   d) approximately 16.5 grams to approximately 18.5 grams of        skimmed milk powder per L of the reconstituted, ready-to-use        nutritional formula;    -   e) approximately 0.02 grams to approximately 0.17 grams of        lactoferrin per L of the reconstituted, ready-to-use nutritional        formula;    -   f) approximately 30.0 grams to approximately 42.0 grams of a        vegetable oil blend comprising the oleic acid-palmitic        acid-oleic acid triglyceride; in which approximately 3.0 grams        to approximately 7.0 grams of the vegetable oil blend is oleic        acid-palmitic acid-oleic acid triglyceride per L of the        reconstituted, ready-to-use nutritional formula;    -   g) approximately 65 grams to approximately 80 grams of lactose        per L of the reconstituted, ready-to-use nutritional formula;    -   h) approximately 0.00006 grams to approximately 0.025 grams of        lutein per L of the reconstituted, ready-to-use nutritional        formula;    -   i) approximately 0.05 grams to approximately 0.09 grams of        docosahexanoic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   j) approximately 0.1 grams to approximately 0.5 grams of        arachidonic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   k) approximately 5 grams to approximately 6.2 grams linoleic        acid per L of the reconstituted, ready-to-use nutritional        formula;    -   l) approximately 0.25 grams to approximately 0.6 grams        alpha-linolenic acid per L of the reconstituted, ready-to-use        nutritional formula;    -   m) approximately 2.0 grams to approximately 5.0 grams of        galactooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   n) approximately 0.10 grams to approximately 0.50 grams of        fructooligosaccharides per L of the reconstituted, ready-to-use        nutritional formula;    -   o) approximately 0.05 grams to approximately 0.15 grams of        Vitamin C, approximately 0.001 grams to approximately 0.05 grams        of Vitamin E per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.01 grams to approximately        0.05 grams of inositol per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.0005 grams to approximately        0.02 grams of Vitamin A per L of the reconstituted, ready-to-use        nutritional formula, approximately 0.005 grams to approximately        0.009 grams of niacin per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.006 grams of Vitamin D3 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.001 grams to approximately 0.005 grams of pantothenic acid per        L of the reconstituted, ready-to-use nutritional formula;        approximately 0.0005 grams to approximately 0.0015 grams of        Vitamin K1 per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.0005 grams to approximately 0.0015        grams of Vitamin B1 per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.00001 grams to        approximately 0.001 grams of Vitamin B2 per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.0001 grams to approximately 0.0008 grams of Vitamin B6 per L        of the reconstituted, ready-to-use nutritional formula;        approximately 0.0001 grams to approximately 0.002 grams of folic        acid per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00001 grams to approximately 0.004        grams of biotin per L of the reconstituted, ready-to-use        nutritional formula; and approximately 0.000001 grams to        approximately 0.0005 grams of Vitamin B12 per L of the        reconstituted, ready-to-use nutritional formula;    -   p) approximately 0.5 grams to approximately 0.8 grams of        dicalcium phosphate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.3 grams to approximately        0.8 grams of calcium carbonate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.3 grams to        approximately 0.5 grams of potassium chloride per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.4 grams to approximately 0.7 grams of tripotassium citrate        monohydrate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.3 grams to approximately 0.5 grams of        sodium citrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.2 grams to approximately        0.5 grams of trisodium citrate dihydrate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.002 grams to approximately 0.006 grams of dimagnesium        phosphate per L of the reconstituted, ready-to-use nutritional        formula; approximately 0.00002 grams to approximately 0.00005        grams of sodium selenite per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.02 grams to        approximately 0.06 grams of iron (II) sulfate per L of the        reconstituted, ready-to-use nutritional formula; approximately        0.01 grams to approximately 0.03 grams of zinc sulfate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.004 grams of copper        sulfate per L of the reconstituted, ready-to-use nutritional        formula; and approximately 0.001 grams to approximately 0.0045        grams of manganese (II) sulfate per L of the reconstituted,        ready-to-use nutritional formula;    -   q) approximately 0.05 grams to approximately 0.1 grams of        adenosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; approximately 0.01 grams to        approximately 0.03 grams of cytidine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;        approximately 0.001 grams to approximately 0.006 grams of        guanosine 5′-monophosphate per L of the reconstituted,        ready-to-use nutritional formula; and approximately 0.01 grams        to approximately 0.03 grams of uridine 5′-monophosphate per L of        the reconstituted, ready-to-use nutritional formula;    -   r) approximately 0.1 grams to approximately 0.5 grams of        L-choline bitartrate per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.005 grams to approximately        0.03 grams of L-carnitine per L of the reconstituted,        ready-to-use nutritional formula;    -   s) approximately 0.0001 grams to approximately 0.0007 grams of        beta-carotene per L of the reconstituted, ready-to-use        nutritional formula; approximately 0.03 grams to approximately        0.07 grams of taurine per L of the reconstituted, ready-to-use        nutritional formula;    -   t) approximately 0.3 grams to approximately 0.5 grams of soya        lecithin per L of the reconstituted, ready-to-use nutritional        formula; and    -   u) approximately 0.00001 grams to approximately 0.00005 grams of        maltodextrin per L of the reconstituted, ready-to-use        nutritional formula.        Embodiment 22. A method of providing nutrition to a subject,        wherein the method comprises: administering the nutritional        formula of embodiment 1 to the subject.        Embodiment 23. The method of embodiment 18, wherein the method        comprises reconstituting the nutritional formula with water to        form a ready-to-feed liquid.        Embodiment 24. A kit comprising:    -   i. one or more packages of the nutritional formula of embodiment        1, in powder form,    -   ii. reconstituting the nutritional formula by adding water; and    -   iii. instructions for administering the nutritional formula to a        subject.

EXAMPLES

In order that the present disclosure may be more fully understood, thefollowing examples are set forth. The examples described in thisapplication are offered to illustrate the nutritional formulas,reconstituted formulas, and methods provided herein and are not to beconstrued in any way as limiting their scope.

Preparation of the Formulations Described Herein

The nutritional formulas provided herein can be prepared from readilyavailable starting materials using the following exemplary methods andprocedures. For example, nutritional formulas can be prepared accordingto Example 1.

Example 1. Exemplary Preparation of Nutritional Formulas Example 1A.First Exemplary Nutritional Formula

This example illustrates a nutritional formula disclosed herein,including a method for making the formula. The formula ingredients arelisted in the following table.

Quantity g/L reconstituted Ingredient formula** Kerry Base:Demineralized whey 24.436 Vegetable blend (contains OPO) 36.519 Wheyprotein concentrate 6.750 Skimmed milk powder 17.550 Mineral PremixCarrier (lactose) 1.059 Dicalcium phosphate (anhydrous) 0.603 Calciumcarbonate (precipitated) 0.497 L-Choline bitartrate (conditioned) 0.459Potassium chloride 0.442 Magnesium chloride 6 H₂O 0.282 Sodium citrate0.396 L-carnitine 0.010968 Potassium Iodide 0.000115 Potassium citrate0.540 Dimagnesium phosphate 3 H₂O 0.000034 Sodium selenite 0.002554Maltodextrin 0.011380 Lactose 39.621 α-lactalbumin enriched Whey Protein2.715 Concentrate Galactoligosaccharides 2.310 Fructooligosaccharides0.257 Soya lecithin 0.414 Lutein 0.021 β-carotene 0.000540 Fungal/AlgalOil Blend (2:1 ARA:DHA) 0.562 Vitamin premix: Vitamin C (ascorbic acid)0.1096875 Carrier (lactose) 0.06934 Taurine 0.067511 Vitamin E 50%(dl-α-tocopheryl acetate, 500 IU) 0.0324 Inositol 0.02565 Vitamin A(retinol palmitate), 250000 IU 0.011275 Niacin (Niacinamide) 0.0081Vitamin D3 (cholecalciferol), 100000 IU 0.0054 Pantothenic acid(calcium-D-pantothenate) 0.003915 Vitamin K1, 5% 0.00135 Vitamin B1(thiamine hydrochloride) 0.00105975 Vitamin B2 (riboflavin) 0.000837Vitamin B6 (pyridoxine hydrochloride) 0.000594 Folic acid 0.00013851Biotin 0.00003915 Vitamin B12 (cyanocobalamin) 0.000003564 Trace mineralpremix: Carrier (lactose) 0.07353 Iron (II) sulfate (dried) 0.046845Zinc sulfate 1H₂O 0.016605 Copper sulfate 0.002646 Manganese (II)sulfate 1H₂O 0.0000018 Nucleotides premix Cytidine 5′-Monophosphate freeacid 0.016416 Uridine 5′-Monophosphate Disodium Salt 0.012798 Guanosine5′-Monophosphate Disodium Salt 0.003672 Adenosine 5′-Monophosphate freeacid 0.00864 Carrier 0.084024 Lactoferrin 0.064 **900 mL of water addedto ingredients to give 1 Liter (L) reconstituted formula

The nutritional formula is typically prepared using a two-step process(e.g., as shown in FIGS. 1A, 1B, and 2 ). The nutritional formula ofExample 1A was prepared using a two-step process outlined below (e.g.,as shown in FIGS. 1A, 1B, and 2 ). The first step involves the additionof macroingredients (e.g., alpha-lactalbumin enriched whey proteinconcentrate, demineralized whey, whey protein concentrate, skimmed milkpowder, and lactose), prebiotics (e.g., galactooligosaccharides andfructooligosaccharides), base mineral premix, lutein, trisodium andtripotassium citrates, and beta-carotene into a base mixing tankcontaining reverse osmosis processed water and outfitted with a highspeed mixer. The vegetable oil blend (e.g., INFAT® fat blend, includingOPO SN-2 oil), DHA/ARA blend and lecithin are then added into the basemixing tank and heated to 140° F. (FIG. 1A).

The slurry is then transferred into a two-stage homogenizer, followed bytransfer to a two-stage pasteurizer. Hot filtered air with a temperatureof approximately 350° F. to approximately 400° F. is used to spray drythe mixture. Sifting is used to trap large particles, wherein theselarger particles are added back into the tall form spray drier toachieve complete drying. When a moisture level of approximately 2.5% toapproximately 2.8% or less is achieved, powder is transferred into apowder hopper for bagging into 25 kg nitrogen flushed bags. Samples aretaken from the powder hopper (FIG. 1B).

The second stage of the process used to prepare nutritional formulainvolves the addition of the vitamin premix, trace minerals premix,nucleotides premix, lactoferrin, and lutein premix to the dry blendbase. This mixture is placed in a small mixer. The addition oflactoferrin at this stage in the process aids in the preservation ofintact ingredients and prevents oxidative degradation during processing,blending, poaching, and storage. The mixture is then transferred into alarge paddle blender. A screen magnet, rotary filler, and composite cancrimper, are used to fill and seal individual containers of the powdernutritional formula, wherein approximately 110 cans of powder can beproduced per minute. The cans are then transferred to a case sealer, andthe completed product is placed into suitable containers fordistribution (FIG. 2 ).

The prepared nutritional formulation of Example 1A is analyzed to obtainthe following nutritional information.

/per /per 100 ml 100 g prepared /per Items powder formula 100 kcal MACRONUTRIENTS Energy, kcal 520 70 100 Protein, g 12.5 1.7 2.4 Fat, g 28.13.8 5.4 OPO, g 3.6 0.5 0.7 Carbohydrate, g 54.6 7.4 10.5 Lactose, g 54.67.4 10.5 Dietary fiber, mg 1920 260 369 Galactoligosaccharides, mg 1730233 332 Fructooligosaccharides, mg 192 26.0 37 Linoleic acid, mg 4420597 850 α-Linolenic acid, mg 406 54.8 78 DHA, mg 50.4 6.8 9.7 ARA, mg101 13.7 19.5 VITAMINS Vitamin A, IU 1560 211 300 Vitamin A re (mcg) 46863.2 90 Vitamin D, IU 312 42.1 60 Vitamin D (mcg) 7.59 1.02 1.46 VitaminE, IU 10.4 1.4 2.0 Vitamin E (mg) a-te 9.36 1.26 1.80 Vitamin K, mcg46.8 6.32 9 Thiamine (Vitamin B1), mcg 416 56.2 80 Riboflavin (VitaminB2), mcg 728 98.3 140 Vitamin B6, mcg 312 42.1 60 Vitamin B12, mcg 1.560.21 0.3 Niacin, mcg 5200 702 1000 Folic acid (Folacin), mcg 83.2 11.216 Pantothenic acid, mcg 3120 421 600 Biotin, mcg 15.6 2.1 3 Vitamin C(Ascorbic acid), mg 62.4 8.42 12 OTHER Choline, mg 125 16.8 24 Inositol,mg 31.2 4.21 6 Nucleotides, mg 20.8 2.81 4 L-Carnitine, mg 6.97 0.941.34 Lutein, mcg 1780 240 342 β-carotene, mcg 98.8 13.3 19 Taurine, mg30.16 4.07 5.8 Lactoferrin, mg 47.3 6.39 9.1 MINERALS Calcium, mg 40654.8 78 Phosphorus, mg 224 30.2 43 Magnesium, mg 41.6 5.6 8 Iron, mg9.36 1.26 1.8 Zinc, mg 5.2 0.7 1 Manganese, mcg 78 10.5 15 Copper, mcg390 52.7 75 Iodine, mcg 78 10.5 15 Selenium, mcg 14.6 1.97 2.8 Sodium,mg 140 19.0 27 Potassium, mg 562 75.8 108 Chloride, mg 327 44.2 62.9

Example 1B. Second Exemplary Nutritional Formula

This example illustrates a second nutritional formula disclosed herein,including a method for making the formula. The formula ingredients arelisted in the following table.

Quantity g/L reconstituted Ingredient formula** Kerry Base:Demineralized whey 24.3 Whey protein concentrate 8.1 Vegetable oil blend(contains OPO) 36.315 Skimmed milk powder 17.550 Mineral Premix: Carrier(lactose) 0.737 Dicalcium phosphate (anhydrous) 0.907 Calcium carbonate(precipitated) 0.450 L-Choline bitartrate (conditioned) 0.461 Potassiumchloride 0.575 Magnesium chloride•6H₂O 0.341 Sodium citrate•2H₂O 0.254L-carnitine 0.011 Potassium iodide (1% on maltodextrin) 0.0201 Potassiumcitrate 0.0000344 Magnesium phosphate 0.0000344 Sodium selenite (1% onmaltodextrin) 0.004914 Sodium chloride 0.0233 Lactose 35.527α-lactalbumin enriched Whey Protein 2.700 ConcentrateGalactoligosaccharides 3.915 Fructooligosaccharides 0.270 Soya lecithin0.412 Lutein 0.016875 β-carotene 0.00054 Trisodium citrate dihydrate0.3375 Tripotassium citrate monohydrate 0.54 Fungal/Algal Oil Blend (2:1ARA:DHA) 0.5616 Vitamin premix: Vitamin C (ascorbic acid) 0.1109 Carrier(lactose) 0.0640 Taurine 0.0694 Vitamin E acetate 0.0347 Inositol 0.0262Vitamin A (retinol palmitate) 0.0114 Niacin (Niacinamide) 0.0082 VitaminD3 (cholecalciferol) 0.0055 Pantothenic acid (calcium-D-pantothenate)0.003896 Vitamin K1 (as Phylloquimone) 0.001364 Vitamin B1 (thiaminehydrochloride) 0.001094 Vitamin B2 (riboflavin) 0.00003753 Vitamin B6(pyridoxine hydrochloride) 0.0005965 Folic acid (Trit on maltodextrin)0.001398 Biotin (as D-biotin on maltodextrin) 0.003954 Vitamin B12 (ascyanocobalamin Trit on 0.0003614 maltodextrin) Trace mineral premix:Carrier (lactose) 0.635 Iron (II) sulfate (dried) 0.04277 Zincsulfate•1H₂O 0.02121 Copper sulfate 0.001733 Manganese (II) sulfate•1H₂O0.001214 Nucleotides premix Cytidine 5′-Monophosphate free acid 0.02136Uridine 5′-Monophosphate Disodium Salt 0.02117 Guanosine5′-Monophosphate Disodium Salt 0.00596 Adenosine 5′-Monophosphate freeacid 0.01136 Carrier 0.07651 Lactoferrin 0.0653 **900 mL of water addedto ingredients to give 1 Liter (L) reconstituted formula

The nutritional formula is typically prepared using a two-step process(e.g., as shown in FIGS. 1A, 1B, and 2 ). The nutritional formula ofExample 1B was prepared using a two-step process outlined below (e.g.,as shown in FIGS. 1A, 1B, and 2 ). The first step involves the additionof macroingredients (e.g., alpha-lactalbumin enriched whey proteinconcentrate, demineralized whey, whey protein concentrate, skimmed milkpowder, and lactose), prebiotics (e.g., galactooligosaccharides andfructooligosaccharides), base mineral premix, lutein, trisodium andtripotassium citrates, and beta-carotene into a base mixing tankcontaining reverse osmosis processed water and outfitted with a highspeed mixer. The vegetable oil blend (e.g., INFAT® fat blend, includingOPO SN-2 oil), DHA/ARA blend and lecithin are then added into the basemixing tank and heated to 140° F. (FIG. 1A).

The slurry is then transferred into a two-stage homogenizer, followed bytransfer to a two-stage pasteurizer. Hot filtered air with a temperatureof approximately 350° F. to approximately 400° F. is used to spray drythe mixture. Sifting is used to trap large particles, wherein theselarger particles are added back into the tall form spray drier toachieve complete drying. When a moisture level of approximately 2.5% toapproximately 2.8% or less is achieved, powder is transferred into apowder hopper for bagging into 25 kg nitrogen flushed bags. Samples aretaken from the powder hopper (FIG. 1B).

The second stage of the process used to prepare nutritional formulainvolves the addition of the vitamin premix, trace minerals premix,nucleotides premix, lactoferrin, and lutein premix to the dry blendbase. This mixture is placed in a small mixer. The addition oflactoferrin at this stage in the process aids in the preservation ofintact ingredients and prevents oxidative degradation during processing,blending, poaching, and storage. The mixture is then transferred into alarge paddle blender. A screen magnet, rotary filler, and composite cancrimper, are used to fill and seal individual containers of the powdernutritional formula, wherein approximately 110 cans of powder can beproduced per minute. The cans are then transferred to a case sealer, andthe completed product is placed into suitable containers fordistribution (FIG. 2 ).

The Example 1B prepared nutritional formulation is analyzed to obtainthe following nutritional information.

/per /per 100 ml 100 g prepared /per Items powder formula 100 kcal MACRONUTRIENTS Energy, kcal 520 70.2 100 Protein, g 12.3 1.7 2.4Alpha-lactalbumin 863 117 166 Fat, g 27 3.6 5.2 OPO, g 3.6 0.5 0.7Linoleic acid, mg 4160 562 800 α-Linolenic acid, mg 312 42.1 60Carbohydrate, g 55 7.4 10.6 Lactose, g 54 7.3 10 Dietary fiber, mg 3100419 596 Galactoligosaccharides, mg 2900 392 558 Fructooligosaccharides,mg 200 27.0 38 DHA, mg 50 6.8 10 ARA, mg 100 13.5 19 VITAMINS Vitamin A,IU 1545 211 300 Vitamin D, IU 309 42 60 Vitamin E, IU 10.3 1.4 2 VitaminK, mcg 46.4 6.3 9 Thiamine (Vitamin B1), mcg 412 56 80 Riboflavin(Vitamin B2), mcg 721 98.3 140 Vitamin B6, mcg 309 42 60 Vitamin B12,mcg 1.5 0.2 0.3 Niacin, mcg 5150 702 1000 Folic acid (Folacin), mcg 8211 16 Pantothenic acid, mcg 2600 355 505 Biotin, mcg 15.5 2.1 3 VitaminC (Ascorbic acid), mg 62 8.5 12 OTHER Choline, mg 124 17 24 Inositol, mg31 4.2 6 Nucleotides, mg 20 2.7 4 L-Carnitine, mg 6.9 0.9 1.34 Lutein,mcg 64 8.7 12 β-carotene, mcg 100 14 19 Taurine, mg 30 4.1 5.8Lactoferrin, mg 47 6.4 9.1 MINERALS Calcium, mg 402 54.8 78 Phosphorus,mg 221 30 43 Magnesium, mg 41 6 8 Iron, mg 9.3 1.3 1.8 Zinc, mg 5.2 0.71 Manganese, mcg 77 10.5 15 Copper, mcg 386 52.6 75 Iodine, mcg 77 10.515 Selenium, mcg 14.4 2.0 2.8 Sodium, mg 139 19 27 Potassium, mg 55675.8 108 Chloride, mg 324 44 62.9

Example 2-1 illustrates a nutritional formula disclosed herein,including a method for making the formula. The formula ingredients arelisted in the following Table 1B.

TABLE 1B g/L Kerry Demineralized whey 24.3000 Base Whey proteinconcentrate 8.100 Vegetable oil blend (contains OPO) 36.315 Skimmed milkpowder 17.550 Mineral Dicalcium phosphate anhydrous 0.907200 PremixCarrier (lactose) 0.737100 Potassium chloride 0.574560 L-Cholinebitartrate (conditioned) 0.461160 Calcium carbonate (precipitated)0.449820 Magnesium chloride 6H2O 0.340956 Sodium citrate 2H2O 0.254016Sodium Chloride 0.023323 Potassium Iodide (1% on Maltodextrin) 0.020072L-carnitine 0.011000 Sodium selenite (1% on Maltodextrin) 0.004914Potassium citrate 0.000034 Magnesium phosphate 0.000034 Lactose 29.276α-lactalbumin enriched WPC 2.700 Fructooligosaccharides 0.270Galactoligosaccharides (Vivinal GOS 3.915 Syrup 59%) Soya lecithin 0.412Lutein 0.017 β-carotene 0.001 Trisodium Citrate Dihydrate 0.338Tripotassium Citriate Monohydrate 0.540 Fungal /Algal Oil Blend (2:10.562 ARA/DHA) DSM Vitamin C (ascorbic acid) 0.111 Vitamin Carrier(lactose) 0.064 Premix Taurine 0.069 Vitamin E Acetate 0.033 Inositol0.026 Vitamin A (retinol palmitate) 0.011 Niacin (Niacinamide) 0.008Vitamin D3 (cholecalciferol) 0.005 Pantothenic acid (calcium-D- 0.004pantothenate) )Vitamin K1 (as Phylloquimone) 0.001 Vitamin B1 (thiaminehydrochloride) 0.001 Vitamin B2 (riboflavin) 0.000 Vitamin B6(pyridoxine hydrochloride) 0.001 Folic acid (Trit on MD) 0.001 Biotin(asD-Biotin on MD) 0.004 Vitamin B12 (as cyanocobalamin 0.000 Trit n MD)DSM Carrier (lactose) 0.635 Mineral Iron (II) sulphate (dried) 0.043premix Zinc sulphate 1H2O 0.021 Copper sulphate 0.002 Manganese (II)sulphate 1H2O Trit MD 0.001 DSM Cytidine 5′-Monophsphate free acid 0.021Nucleotides Uridine 5′-Monophosphate Disodium 0.021 Salt premixGuanosine 5′-Monophosphate Disodium 0.006 Salt Adenosine5′-Monophosphate free acid 0.011 Carrier (lactose) 0.077 DSM LuteinLutein 5% SD/S (DSM 0.007 Premix Lactose 5.670 FN-200408 Lactoferrin0.065 (Milei MLF - 2M) ** 900 mL of water added to ingredients to give 1Liter (L) reconstituted formula

Example 2-2 illustrates a nutritional formula disclosed herein,including a method for making the formula. The formula ingredients arelisted in the following Table 1C.

TABLE 1C g/L g/100 g Kerry Base 9265 Demineralized whey 24.300 18.000020492074 Whey protein concentrate 8.100 6.0000 Vegetable oil blend(contains OPO) 36.315 26.9000 Skimmed milk powder 17.550 13.0000 MineralPremix Dicalcium phosphate anhydrous 0.907200 0.6720000 RE29249/ACarrier (lactose) 0.737100 0.5460000 Potassium chloride 0.5745600.4256000 L-Choline bitartrate (conditioned) 0.461160 0.3416000 Calciumcarbonate (precipitated) 0.449820 0.3332000 Magnesium chloride 6H2O0.340956 0.2525600 Sodium citrate 2H2O 0.254016 0.1881600 SodiumChloride 0.023323 0.0172760 Potassium Iodide (1% on Maltodextrin)0.020072 0.0148680 L-carnitine 0.011000 0.0081480 Sodium selenite (1% onMaltodextrin) 0.004914 0.0036400 Potassium citrate 0.000034 0.0000255Magnesium phosphate 0.000034 0.0000255 Lactose 29.276 21.685556α-lactalbumin enriched WPC 2.700000 2.000000 Fructooligosaccharides0.270000 0.200000 Galactoligosaccharides (Vivinal GOS Syrup 59%)3.915000 2.900000 Soya lecithin 0.411750 0.305000 Lutein 0.0168750.012500 β-carotene 0.000540 0.000400 Trisodium Citrate Dihydrate0.337500 0.250000 Tripotassium Citriate Monohydrate 0.540000 0.400000Fungal/Algal Oil Blend (Formulaid 2:1 ARA/DHA) 0.561600 0.416000 DSMVitamin Vitamin C (ascorbic acid) 0.110893 0.0821433 Premix Carrier(lactose) 0.063952 0.0473715 XR71008 Taurine 0.069351 0.0513711 VitaminE Acetate 0.032724 0.0242400 Inositol 0.026166 0.0193819 Vitamin A(retinol palmitate) 0.011389 0.0084360 Niacin (Niacinamide) 0.0082460.0061080 Vitamin D3 (cholecalciferol) 0.005454 0.0040400 Pantothenicacid (calcium-D-pantothenate) 0.003896 0.0028861 (Vitamin K1 (asPhylloquimone) 0.001364 0.0010100 Vitamin B1 (thiamine hydrochloride)0.001094 0.0008105 Vitamin B2 (riboflavin) 0.000038 0.0000278 Vitamin B6(pyridoxine hydrochloride) 0.000597 0.0004419 Folic acid (Trit on MD)0.001398 0.0010353 Biotin (asD-Biotin on MD) 0.003954 0.0029290 VitaminB12 (as cyanocobalamin Trit n MD) 0.000361 0.0002677 DSM Mineral Carrier(lactose) 0.635282 0.4705792 premix Iron (II) sulphate (dried) 0.0427660.0316784 XR71284 Zinc sulphate 1H2O 0.021214 0.0157144 Dosage Coppersulphate 0.001733 0.0012840 100 mg/100 kcal Manganese (II) sulphate 1H2OTrit MD 0.001214 0.0008996 DSM Nucleotides Cytidine 5′-Monophsphate freeacid 0.021357 0.0158198 premix Uridine 5′-Monophosphate Disodium Salt0.021171 0.0156823 XR71224 Guanosine 5′-Monophosphate Disodium Salt0.005956 0.0044117 Adenosine 5′-Monophosphate free acid 0.0113590.0084143 Carrier (lactose) 0.076507 0.0566721 DSM Lutein Lutein 1% SD/S(DSM 0.007324 0.0054250 Premix XR Lactose 5.670000 4.2000000 Lactoferrin0.065286 0.048 (Milei MLF - 2M) 100.000000

Example 2-3 illustrates a nutritional formula disclosed herein,including a method for making the formula. The formula ingredients arelisted in the following Table 1D.

TABLE 1D g/L g/100 g Kerry Base Demineralized whey 24.300 18.0000 Wheyprotein concentrate 8.100 6.0000 Vegetable oil blend (contains OPO)36.315 26.9000 Skimmed milk powder 17.550 13.0000 Mineral PremixDicalcium phosphate anhydrous 0.907200 0.6720000 Canier (lactose)0.737100 0.5460000 Potassium chloride 0.574560 0.4256000 L-Cholinebitartrate (conditioned) 0.461160 0.3416000 Calcium carbonate(precipitated) 0.449820 0.3332000 Magnesium chloride 6H2O 0.3409560.2525600 Sodium citrate 2H2O 0.254016 0.1881600 Sodium Chloride0.023323 0.0172760 Potassium Iodide (1% on Maltodextrin) 0.0200720.0148680 L-carnitine 0.011000 0.0081480 Sodium selenite (1% onMaltodextrin) 0.004914 0.0036400 Potassium citrate 0.000034 0.0000255Magnesium phosphate 0.000034 0.0000255 Lactose 34.949741 25.888697α-lactalbumin enriched WPC 2.700000 2.000000 Fructooligosaccharides0.270000 0.200000 Galactoligosaccharides (Vivinal GOS Syrup 59%)3.915000 2.900000 Soya lecithin 0.411750 0.305000 Lutein 0.0206550.015300 β-carotene 0.000540 0.000400 Trisodium Citrate Dihydrate0.337500 0.250000 Tripotassium Citriate Monohydrate 0.540000 0.400000Fungal/Algal Oil Blend (Formulaid B 2:1 ARA/DHA) 0.561600 0.416000 DSMVitamin Vitamin C (ascorbic acid) 0.110893 0.0821433 Premix Carrier(lactose DC) 0.063952 0.0473715 XR72986 Taurine 0.069351 0.0513711Vitamin E Acetate 0.032724 0.0242400 Inositol 0.026166 0.0193819 VitaminA (retinol palmitate) 0.011389 0.0084360 Niacin (Niacinamide) 0.0082460.0061080 Vitamin D3 (cholecalciferol) 0.005454 0.0040400 Pantothenicacid (calcium-D-pantothenate) 0.003896 0.0028861 )Vitamin K1(Phylloquimone SD Gran) 0.001364 0.0010100 Vitamin B1 (thiaminehydrochloride) 0.001094 0.0008105 Vitamin B2 (riboflavin) 0.0000380.0000278 Vitamin B6 (pyridoxine hydrochloride) 0.000597 0.0004419 Folicacid (Trit on DCP) 0.001398 0.0010353 Biotin (asD-Biotin on DCP)0.003954 0.0029290 Vitamin B12 (as cyanocobalamin Trit DCP) 0.0003610.0002677 DSM Mineral Carrier (lactose) 0.629673 0.4664244 premix Iron(II) sulphate (dried) 0.049182 0.0364312 XR72987 Zinc sulphate 1H2O0.021214 0.0157144 Copper sulphate 0.001523 0.0011284 Manganese (II)sulphate 1H2O 0.000407 0.0003016 DSM Nucleotides Cytidine5′-Monophsphate free acid 0.021356 0.0158196 premix Uridine5′-Monophosphate Disodium Salt 0.021171 0.0156823 XR71224 Guanosine5′-Monophosphate Disodium Salt 0.005956 0.0044117 Adenosine5′-Monophosphate free acid 0.011359 0.0084143 Carrier (lactose) 0.0765070.0566721 Lactoferrin 0.064800 0.0480000 (Milei MLF - 2M) 100.00000

The nutritional formula is typically prepared using a two-step process(e.g., as shown in FIGS. 1A, 1B, and 2 ). The nutritional formula ofExamples 2-1, 2-2, and 2-3 were prepared using a two-step processoutlined below (e.g., as shown in FIGS. 1A, 1B, and 2 ). The first stepinvolves the addition of macroingredients (e.g., alpha-lactalbuminenriched whey protein concentrate, demineralized whey, whey proteinconcentrate, skimmed milk powder, and lactose), prebiotics (e.g.,galactooligosaccharides and fructooligosaccharides), base mineralpremix, lutein, trisodium and tripotassium citrates, and beta-caroteneinto a base mixing tank containing reverse osmosis processed water andoutfitted with a high speed mixer. The vegetable oil blend (e.g., INFAT®fat blend, including OPO SN-2 oil), DHA/ARA blend and lecithin are thenadded into the base mixing tank and heated to 140° F. (FIG. 1A).

The slurry is then transferred into a two-stage homogenizer, followed bytransfer to a two-stage pasteurizer. Hot filtered air with a temperatureof approximately 350° F. to approximately 400° F. is used to spray drythe mixture. Sifting is used to trap large particles, wherein theselarger particles are added back into the tall form spray drier toachieve complete drying. When a moisture level of approximately 2.5% toapproximately 2.8% or less is achieved, powder is transferred into apowder hopper for bagging into 25 kg nitrogen flushed bags. Samples aretaken from the powder hopper (FIG. 1B).

The second stage of the process used to prepare nutritional formulainvolves the addition of the vitamin premix, trace minerals premix,nucleotides premix, lactoferrin, and lutein premix to the dry blendbase. This mixture is placed in a small mixer. The addition oflactoferrin at this stage in the process aids in the preservation ofintact ingredients and prevents oxidative degradation during processing,blending, poaching, and storage. The mixture is then transferred into alarge paddle blender. A screen magnet, rotary filler, and composite cancrimper, are used to fill and seal individual containers of the powdernutritional formula, wherein approximately 110 cans of powder can beproduced per minute. The cans are then transferred to a case sealer, andthe completed product is placed into suitable containers fordistribution (FIG. 2 ).

The Examples 2-1, 2-2, and/or 2-3 prepared nutritional formulations areand/or were analyzed using standard analytical techniques in the fieldfor the clinical and Protein Efficiency Ratio (PER) study in rats, toobtain the following nutritional information and microbiologyinformation for lots #1 and #2 shown in Table 1A.

TABLE 1A Nutritional information and microbiology information forExample 2-1, Example 2-2, Example 2-3, Tables 1B, 1C, and/or 1D. per 100g of Powder per 100 kcal Lot Lot Average Label Lower Upper Average LabelAnalytical #1 #2 Results Claim Limit Limit Results Claim Protein, g 13.613.6 13.6 13.0 13.0 14.0 2.7 2.5 Fat, g 26.3 26.3 26.3 26.0 26.0 28.85.2 5.1 OPO, g 3.7 3.7 3.7 3.6 3 8 0.7 0.7 Linoleic acid, mg 4550 45204535 4420 4420 4600 896 850 α-Linolenic acid, mg 393 390 392 312 312 40077 60 Carbohydrate, g* 54.6 54.6 54.6 54 54 65 10.8 10.5 Lactose, g**50.3 49.6 50 49 49 72 9.9 9.5 Dietary Fiber, mg 1737 1759 1748 1716 11003300 345 330 Galactooligosaccharides mg 1560 1570 1565 1560 1000 3000309 300 Fructooligosaccharide mg 177 189 183 156 100 300 36 30 DHA, mg51 52 52 50 50 60 10.2 9.6 ARA, mg 105 105 105 100 100 120 21 19Vitamins 0.0 Vitamin A, IU 3180 2337 2759 1560 1560 3700 545 300 VitaminD, IU 442 416 429 312 312 520 85 60 Vitamin E, IU 14.5 13.5 14.0 10.410.4 15 3 2 Vitamin K, mcg 73.6 75.1 74.4 46.8 46.8 80.0 15 9 Thiamine(Vitmain B1), mcg 803 821 812 416 416 850 160 80 Riboflavin (VitaminB2), mcg 1400 1380 1390 728 728 1500 275 140 Vitamin B6, mcg 432 430 431312 312 450 85 60 Vitmain B12, mcg 5.76 5.36 5.6 1.5 1.6 9.6 1 0.3Niacin, mcg 6560 5850 6205 5200 5200 6600 1226 1000 Folic acid(Folacin), mcg 101 106 104 83 83 110 20 16 Pantothenic acid, mcg 42804060 4170 3120 3120 4300 824 600 Biotin, mcg 37.4 31.8 34.6 15.6 15.640.0 7 3 Vitamin C (Ascorbic acid), mg 80.2 98.5 89 62 62 120 18 12Other 0.0 Choline, mg 195 189 192 125 125 250 38 24 Inositol, mg 37.937.4 38 31 31 40 7 6 Nucleotides, mg 36.8 38.3 38 20 20 40 7 4L-Carnitine, mg 18.5 18.3 18 6.8 6.8 50 3.6 1.3 Lutein, mcg 63.5 75.6 7052 30 200 14 10 β-carotene, mcg 128 130 129 98 98 240 25 19 Taurine, mg58.7 55.3 57 31 31 60 11 6 Lactoferrin 98.7 98.5 99 47 47 120 19 9Moisture 2.30 2.23 2.27 — — <3 0.45 <3 Minerals 0.0 Calcium, mg 553 563558 402 402 700 110 78 Phosphorus, mg 364 363 364 221 221 450 72 43Magnesium, mg 59.7 59.4 60 41 41 75 12 8 Iron, mg 9.8 10.1 10.0 9.3 9.315.0 2.0 1.8 Zinc, mg 6.33 6.53 6.4 5.2 5.2 7.0 1 1 Manganese, mcg 152152 152 77 77 160 30 8 Copper, mcg 432 471 452 386 386 463 89 75 Iodine,mcg 174 176 175 77 77 375 35 15 Selenium, mcg 24.7 24.7 24.7 14.4 14.435.0 4.9 2.8 Sodium, mg 230 236 233 139 139 300 46 27 Potassium, mg 679685 682 556 556 1000 135 108 Chloride, mg 432 432 432 324 324 750 85.463.0 Microbiology Lot #1 Lot #2 Salmonella Pass Pass Neg/25 gEnterobacter Sakazakii #1 Pass Pass Absent/100 g Enterobacter Sakazakii#2 Pass Pass Absent/100 g Enterobacter Sakazakii #3 Pass Pass Absent/100g Enterobacteriaceae Count Pass Pass <10 CFU¹/g Listeria Pass PassNeg/25 g Staphylococcus Pass Pass <10 CFU/g Yeast Count Pass Pass <10CFU/g Mold Count Pass Pass <10 CFU/g Aerobic Plate Count Pass Pass<1,000 CFU/g Bacillus Cereus Plate Count Pass Pass <100 CFU/gClostridium Perfringens Pass Pass <10 CFU/g Total Coliforms Pass Pass<10 CFU/g Escherichia Coli Pass Pass <10 CFU/g ¹CFU refers to colonyforming units.

Example 2A

The standard analytical techniques in the field were used for theclinical and Protein Efficiency Ratio (PER) study in rats, to obtain thefollowing nutritional information and microbiology information for lots#1 and #2 shown in Table 1A are as described below. The testing followedthe guidelines in Protein Efficiency Ratio. AOAC Official Method 960.48,Paragraph 45.3.04. AOAC International (18^(th) Edition, 2005) FO-1,Determination of Protein Rating. Official Method, Health ProtectionBranch, Ottawa. Oct. 15, 1981, and was as described below.

Purpose

The Protein Efficiency Ratio (PER) study was conducted to demonstratethat the protein in the Test Article meets the quality factor ofsufficient biological quality of protein by establishing the biologicalquality of the protein in the finished product when fed as a sole sourceof nutrition using an appropriate modification of the Protein EfficiencyRatio (PER) rat bioassay described in the “Official Methods of Analysisof AOAC International”, 18th ed., sections 45.3.04 and 453.05, “AOACOfficial Method 960.48 Protein Efficiency Ratio Rat Bioassay,” which isincorporated by reference at 106.160.

Background

Whether the protein ingredients of infant formula (typically bovinemilk, whey concentrates and/or protein hydrolysates) retain their fullcomplement of bioavailable amino acids through the infant formulamanufacturing process is tested experimentally. Formation of Maillardreaction products, generated during the thermal processes of formulaproduction, may negatively impact the protein quality of the formula(Boye, Wijesinha-Bettoni, & Burlingame, 2012). This reaction has thepotential to dramatically reduce the lysine content of thermallyprocessed foods. For example, Mitchel et al. reported that the ProteinEfficiency Ratio (PER) of non-fat dried skim milk was 3.2 g weight gainper g of protein consumed, whereas that of the same protein which hadbeen heated was only 1.7 g/g (Mitchell, Jenkins, & Grundel, 1989). Inaddition to loss of protein quality through the Maillard reaction,protein quality may be negatively affected by other factors, as outlinedby Boye et al. (2012).

Dietary Protein Concentration

The growth rate of rats depends on the amount of protein present intheir diet, a fact that has been recognized for 100 years (Osborne, T.,Mendel, L., Perry, 1919). Rats consuming diets with increasingconcentrations of casein reach a weight plateau when the proteinconcentration constitutes approximately 16% of total diet (Mercer, May,& Dodds, 1989). Below that level a dose-response relationship existsbetween protein concentration and growth (Finke, DeFoliart, & Benevenga,1987, Mercer et al., 1989). Therefore, at a dietary proteinconcentration of 10%, the concentration typically used in PER studies,feeding diets containing low quality protein (diets with low levels ofeven one essential amino) will result in a relatively low level ofweight gain per gram of diet consumed. With ANCR casein as a control,all diets should be formulated to contain as close to 10% protein aspossible.

B. Sulfur Containing Amino Acids

Methionine and cystine are both sulfur containing amino acids, whileonly methionine is considered an essential amino acid. This is becausemethionine is endogenously converted to cystine; if cystine is presentin the diet it can reduce the dietary methionine requirement by up to50% (NRC, 1995; Shannon, Howe, & Clark, 1972). The AOAC PER methodrequires a casein control group with no added sulfur containing aminoacids. The amount of sulfur containing amino acids present in a 10%casein control diet places rats on a sensitive part of the weight gaindose-response curve (Gahl, Finke, Crenshaw, & Benevenga, 1991;Benevenga, Gahl, Crenshaw, & Finke, 1994). Supplementation withadditional sulfur containing amino acids is not required.

C. Lactose Intolerance

All mammalian milk contains lactose (a glucose-galactose dimer) as theprinciple carbohydrate. The hydrolytic action of intestinal lactaseproduces the individual monomers, which are absorbed. Intestinal lactaseactivity is high in the rat small intestine until weaning, at whichpoint a dramatic decrease occurs (Tadesse, 1990). Lactose fed to adultrats is poorly absorbed in the small intestine. It is treated as adietary fiber and is fermented in the cecum resulting in a threefoldincrease in cecal weight compared to animals receiving a comparableamount of the maltodextrin, the primary carbohydrate found in AIN 93G(van de Heijning et al., 2015).

Exemplary infant formulas contain lactose as the primary carbohydrate.It is essential that control diets and formula-containing diets arebalanced for lactose levels. In addition, animals must be as close aspossible to the same age and weight in all study groups at studyinitiation, thus minimizing differences in the loss of intestinallactase during the study. In studies requiring high lactose diets,exposing all animals to a modest length acclimation period (5-7 days) isrecommended. Experimental work from the FDA demonstrated that the weeklyPER (over a four week test period) of infant formulas devoid of lactose(soy-based formulas) ranged from 2.9-3.7 g/g, while lactose containingformulas (milk-based) had much lower PERs, ranging from 1.0-2.3 g/g (G.V. Mitchell & Jenkins, 1985). Experimental and control PER diets shouldcontain the same amount of lactose.

Summary of PER Study

All diets were prepared by Dyets Inc. to target the AOAC test methodnutrient content, and to meet the minimum nutritional requirements ofthe rats (see Appendices A and B). Prior to study initiation the testdiet and control diets were subjected to analysis to assess suitabilityas comparators. The diets were analyzed for protein which was used tocalculate the protein consumption by the rats. The PER (body weight gaindivided by protein consumption) was calculated for each animal.

In preparation for the test, a group of Sprague-Dawley derived, albinorats were received from Envigo, RMS Inc. The animals were singly housedin suspended stainless steel caging.

Litter paper was placed beneath the cages and was changed at least threetimes per week. The animal room was temperature controlled and had a12-hour light/dark cycle. The animals were fed an acclimation diet(Modified casein control Diet) and filtered tap water was supplied adlibitum. The animals were observed daily and body weights and dietconsumption were also measured and recorded daily. Following a 6-dayacclimation period, the animals were weighed and examined for health.Forty (40) healthy naive male rats (not previously tested) were selectedand randomly distributed (10/group) into each of the test or controlgroups.

The test and control diets were presented ad libitum to the animals fromeach group for 28 consecutive days. Body weights were recorded prior toinitiation (Day 0) and at least twice each week thereafter. Individualdiet consumption was measured and recorded weekly. At study termination,all animals were euthanized by CO₂ inhalation.

Total individual body weight gain and diet consumption were calculatedfor each animal over the 4-week test period. Protein consumption wascalculated by multiplying total diet consumption by the percent ofprotein contained in the prepared diet. The PER (body weight gaindivided by protein consumption) was calculated for each animal usingthese values. An adjusted PER was calculated by “normalizing” the testgroup to Casein at a PER of 2.5.

Storage

The test and control diets were stored refrigerated under a nitrogenblanket except when presented to the rats.

General Test System Parameters

Animal Requirements

Number of Animals: 40

Number of Groups: 4

Number of Animals per Group: 10

Sex: Male

Species/Strain: Rat/Sprague-Dawley derived, albino

Age/Weight: Arrival: 21-23 days/38.4-48.1 grams

Study Start: 27-29 days/46.1-57.8 grams

Test System Justification

The rat is the system of choice because, historically, it has been thepreferred and most commonly used species for protein efficiency testing.

Husbandry

Housing: Animals were housed individually in suspended stainless steelcages which conform to the size recommendations in the most recent Guidefor the Care and Use of Laboratory Animals (Natl. Res. Council, 2011).Litter paper placed beneath the cage and was changed at least threetimes/week. The animal room had a 12-hour light/dark cycle and was keptclean and vermin free. Environmental controls were set to maintaintemperature and relative humidity ranges of 21±2° C. and 30-70%,respectively. The observed values/ranges are documented in the raw data.In addition, airflow in the animal room was maintained at or above 10air changes per hour.

Animal Room Temperature and Relative Humidity Ranges: 19-22° C. and29-68%, respectively.

Animal Room Air Changes/Hour: 21 or 22. Airflow measurements areevaluated regularly and the records are kept on file at Product SafetyLabs.

Photoperiod: 12-hour light/dark cycle

Acclimation: The animals were conditioned to the housing facilities forsix days prior to testing.

Food: During the acclimation period, animals were fed Modified caseincontrol Diet, ad libitum. During the study, animals were offered theirrespective test or control diets ad libitum according to their assignedgroup.

Water: Filtered tap water was available ad libitum.

Contaminants: There are no known contaminants reasonably expected to befound in the food or water at levels which would interfere with theresults of this study. Analysis of the water is conducted regularly andthe results are kept on file at PSL.

Identification

Cage: Each cage was identified by a cage card indicating the studynumber, dose group, identification, and sex of the animal.

Animal: Each animal was uniquely identified with a stainless steel eartag or color marking. Animals assigned to test were also assigned asequential animal number. Except for acclimation data, only thesequential animal number is presented in this report.

Experimental Design

Route of Administration

The test and control articles were administered in the diet.

Justification of Route of Administration

The dietary route of administration was used because it is recommendedin the referenced guidelines, and because it is the intended route ofhuman exposure.

Control of Bias

Animals were randomly assigned to test groups, stratified by bodyweight.

Dose Groups

Ten male animals were assigned to each of the following test groups:

Group No. Product No. Animals/Group Protein Source Description 1 10 TestArticle Diet Solid 2 10 Modified Casein Control Diet Solid 3 10 StandardCasein Control Diet Solid 4 10 Enfamil ® Comparison Diet SolidProcedureAnalysis

Prior to diet formulation, a Certificate of Analysis was obtained forthe batch of test article to be used in the study. This Certificate ofAnalysis includes the results of a proximate analysis, a carbohydrateprofile and analysis of the vitamins and minerals contained in the testarticle.

Prior to preparation of the diets, the test article was analyzed for thebelow listed parameters.

Moisture Lactose Ash Total fat Protein Total Carbohydrates Crude FiberVitamin content Mineral content

A proximate analysis was completed for the batch of casein to be used onthe study along with select minerals commonly found in casein. Casein isnot known to contain any vitamins at a level that would have any impacton the outcome of the study.

Following diet formulation, all diets were subjected to a proximateanalysis. Since the objective of this study was to evaluate thebiological quality of the protein, the protein content of each diet wasconfirmed from 3 representative samples, generally the top, middle andbottom of the bulk diet, to demonstrate homogeneity of the diet mix. Themean of these values was considered the protein content for each diet. Adiet was deemed homogeneous if the % RSD was within 5%. The mean proteinvalue should be between 9.5% and 11% (target protein concentration is10%) of the respective diet. A sample of each diet was collected andstored frozen for analysis.

In addition, the concentration of Lactose (where applicable) in thefinal diets was confirmed. The remaining carbohydrates were notanalyzed.

Finally, one representative vitamin (Riboflavin) and mineral (zinc) forthe purpose of demonstrating proper addition of the vitamin and mineralpre-mixes was confirmed by analysis.

Diet Formulations

The formulation of all diets were guided by the AOAC published methodfor the PER test. The test diet was formulated with appropriatemodifications of the AOAC method to minimize the addition of nutrients²other than those necessary to ensure the diet meets the minimumnutritional requirements of the rat (with the exception of protein). ²Asclarified by the FDA, this is to comply with the final rule which statesthe protein quality must be demonstrated in the infant formula.

Once the final test diet was formulated, a modified control diet wasformulated to be comparable in all of its ingredients (to the extentpossible) to the final test diet. After assuring 10% protein (by wt.),adjustments were made to carbohydrate sources, total fat (andpotentially fat sources) and total crude fiber along with all vitaminsand minerals.

The Standard Casein Control Diet (Group 3) was formulated to beconsistent with the AOAC prescribed method. The sole source of proteinwas casein and the fat source was soybean oil. Carbohydrate sources werelimited to sucrose and corn starch. Vitamin and mineral content in thestandard casein control diet were provided via standard premixesdesigned to meet all of the NRC recommended minimum requirements for thegrowing rat.

The addition of the infant formula product satisfies or exceeds many ofthe vitamin and mineral requirements of the rats. Therefore, the testdiet was supplemented only with those individual vitamin and mineralsneeded to bring all necessary micronutrients up to required levels forthe rat.

The modified control diet was then supplemented with sufficient vitaminand mineral premixes to bring all micronutrients to the minimum requiredlevels and then individually supplemented as necessary to be moreclosely aligned with the final levels achieved in the test diet.

Adjustments to the Test Diet (Group 1) and Enfamil® Comparison Diet(Group 4) was determined from the analysis of the respective testarticle (BBN Formula or Enfamil® Formula). The Modified Casein ControlDiet (Group 2) was formulated to match the macronutrient andmicronutrient contents of their respective Test Diet (Group 1)³. TheModified casein control and Test diets contained 10% protein (wt/wt) tobe in line with typical diets used for PER and the carbohydrate contentwere adjusted with the focus on matching the lactose of the modifiedcasein control diet to the test diet followed by consideration of theremaining carbohydrates to the extent possible. Due to the high volumeof oil and potentially additional moisture to be added to the modifiedcasein control, further addition of sugars to the modified caseincontrol may result in diets that are unappealing or physically noteditable to the rats. The use of corn starch, as prescribed by the AOACmethod, to fill out the balance of the modified casein control diet wasused as needed to ensure better absorption and distribution of the fatsource in the diet. The ability of the rats to routinely consume thediets was paramount relative to any other considerations that may havebeen given to the matching of the carbohydrate sources beyond thelactose. ³The Enfamil® diet is for commercial comparison to the testdiet, therefore it does not have a corresponding modified control diet.

Casein was used as the sole protein source for the Modified caseincontrol Diet. Carbohydrate sources used in the Test Article were used inthe Modified casein control Diet to achieve similar carbohydrate contentif possible (as previously described), with specific attention on thelactose content. The oil blend used in the Test Article was used in theModified casein control Diet to achieve the same fatty acid content. Afull list of ingredients for both the Standard casein control andModified casein control Diets and the Test Diet formulations, and theiranalyses are presented in Appendices A-D.

Test Diet Preparation

All diets were prepared by Dyets Inc. Sufficient quantity of theModified casein control Diet was prepared so that all animals were fedthis diet during the acclimation period.

Animal Selection

Ten healthy rats within the designated age range were selected for eachtest/control group. Animals were selected for test on the basis ofadequate body weight gain and freedom from clinical signs of disease orinjury. Selected rats were randomly assigned to groups, stratified bybody weight.

Diet Consumption

The rats were fed their respective diets ad libitum for 28 consecutivedays. Individual diet consumption was measured and recorded daily duringacclimation and twice weekly during the test after taking into accountany measured spillage.

Body Weight

Individual body weights were recorded daily during acclimation, on thefirst day of diet presentation, and twice weekly thereafter.

Clinical Observations

All animals were observed twice daily for viability. Clinicalobservations were performed and recorded daily, and included, but wasnot limited to, gross evaluation of skin and fur, eyes and mucousmembranes, respiratory, circulatory, autonomic and central nervoussystems, somatomotor activity and behavior pattern. Particular attentionwas directed to symptoms associated with a high-lactose diet (diarrhea,soft stools, red discoloration on fur, oily coat, etc.).

Calculation of Per

Individual body weight gain, diet consumption and protein consumptionfor the entire 28-day test period were tabulated and individual,experimental PERs were calculated as follows:

${{Experimental}{\mspace{11mu}\;}{PER}} = \frac{{bodyweight}\mspace{14mu}{gain}\mspace{11mu}(g)}{{protein}\mspace{14mu}{consumed}\mspace{11mu}(g)}$

The experimental PERs of the test groups were also adjusted relative tothe casein control to calculate an adjusted PER:

${{Adjusted}{\mspace{11mu}\;}{PER}} = \frac{{experimental}\mspace{14mu}{PER}\mspace{14mu}\left( {{test}\mspace{14mu}{group}} \right) \times 2.5}{{experimental}\mspace{14mu}{PER}\mspace{14mu}({casein})}$

The mean experimental and adjusted PER values are reported for eachgroup.

Statistical Analysis

Statistical analysis was the calculation of mean and standarddeviations. In addition, a one-way ANOVA was conducted on experimentalPER values comparing all test groups to the casein control group.

Study Conduct

Test Procedure Guidelines

The procedures described in this test method were based on one or moreof the following testing guidelines:

Protein Efficiency Ratio. AOAC Official Method 960.48, Paragraph45.3.04. AOAC International (18^(th) Edition, 2005)

FO-1, Determination of Protein Rating. Official Method, HealthProtection Branch, Ottawa. Oct. 15, 1981

Results and Conclusion

Total weight gain for each group over time is presented in FIG. 3 .Individual total diet consumption for each group is presented in Tables2A-F. Experimental PER is presented in Tables 3A-D. Individual dailyin-life observations for each group are presented in Table 4. The TestMethod and the results of diet analyses are presented in Appendices A,B, B1, C, and D.

Analytical confirmation results of both the test and control finisheddiets demonstrated that the diets were nutritionally comparable, withthe only notable difference being the source of protein. Differencesobserved in the growth of the rats per gram of protein consumed areattributed to the protein source within each diet.

One Group 3 animal (1028) was found dead on Day 12. Apart from a reducedfecal volume on Days 10-11, the animal appeared active and healthy andwas gaining body weight. Gross necropsy observations of the decedentrevealed slight dilation of the kidneys, slight discoloration of thelungs, and white frothy liquid in the trachea. Although the cause ofdeath was not determined, this animal's death is not considered to berelated to the casein diet. Further, this animal's death has no impacton the outcome of the study. The animal was removed from the Group 3averages in the below Table A2.

TABLE A2 Group Mean Bodyweight (g) Diet Protein Mean Protein MeanAdjusted No. Initial Final Gain Consumption (g) in Diet (%) Consumption(g) Exp. PER PER 1 53.2 163.3 110.1 307.8 9.92 30.5 3.62** 3.28 2 53.1124.3 71.2 259.8 9.9 25.7 2.76 2.50 3 53.0 169.8 117.09 369.79 10.0437.13 3.15** 2.86 4 53.3 145.2 91.9 276.7 9.88 27.3 3.37** 3.05 **p <0.01 in comparison to Group 2 by Dunnett's Multiple Comparisons Test.

According to AOAC Method 960.48, the protein quality of the Test ArticleDiet was 131.2%⁴ of the adjusted PER for the Modified Casein ControlDiet, respectively. The Test Article Diet was also found to have aprotein quality that was 107.5% of the adjusted PER for the Enfamil®Comparison Diet. ⁴(Adj. PER of Test Diet/Adj. PER of Control Diet)*100

According to AOAC Method 960.48, the protein quality of the StandardCasein Control Diet was 114.4% of the adjusted PER for the ModifiedCasein Control Diet, respectively.

According to AOAC Method 960.48, the protein quality of the Enfamil®Comparison Diet was 122% of the adjusted PER for the Modified CaseinControl Diet, respectively.

APPENDIX A

Diet Formulation for Production (Recipe) Modified Standard Enfamil ®Individual Casein Casein Comparison Ingredient Test Diet Control ControlDiet Nutrient to add g/kg g/kg g/kg g/kg Formulation A Test Article735.30 Casein, 80 Mesh, DYETS Casein 115.50 115.50 #400601, Lot # 20017Enfamil ® Infant Formula Comparison Test Article 976.6 Fat (Soybean Oil)Soybean Oil 78.60 Fat: Sponsor Fat Blend 192.00 Moisture: 13.30 5.300.00 21.3 Ash: Mineral Mix 0.00 31.01 41.89 0 Sodium (Na) SodiumChloride (39.3% Na) 0.0000 2.090842 0 Chloride (Cl) (60.7% Cl) Calcium(Ca) Calcium Carbonate (40.0% Ca) 2.2426 0.726817 0.32912 Phosphorous(P) Potassium Phosphate, Monobasic (28.7% 1.4350 2.835375 1.76423 K,22.8% P) Potassium (K) Potassium Citrate - 1 H2O (36.2% K) 0.00004.520292 0 Magnesium (Mg) Magnesium Sulfate, Anhydrous (9.9% 0.10300.759867 0 Mg, 13% S) Sulfur (S) Potassium Sulfate (44.9% K, 18.4% S)0.0000 0 0 Chromium (Cr) Chromium K Sulfate - 12 H2O (10.4% 0.0000 0 0Cr, 7.8% K, 12.8% S) Copper (Cu) Cupric Carbonate (57.5% Cu) 0.00290.000175 0.00012 Fluoride (F) Sodium Fluoride (45.2% F, 54.8% Na) 0.00000 0 Iodine (I) Potassium Iodate (59.3% I, 18.2% K) 0.0000 0.001992 0Iron (Fe) Ferric Citrate (17.4% Fe) 0.0000 0.219117 0 Manganese (Mn)Manganese Carbonate (47.8% Mn) 0.0186 0.002367 0.01874 Molybdenum (Mo)Ammonium Molybdate - 4 H2O (54.3% 0.0003 0.000167 0.000276 Mo) Selenium(Se) Sodium Selenate (41.8% Se) 0.0000 0.000142 0 Zinc (Zn) ZincCarbonate (52.1% Zn) 0.0000 0.038442 0

TABLE A1 List of ingredients and nutrients in Test Diets of ModifiedCasein Control Diet, Standard Casein Control, and Enfamil ® ComparisonDiet Modified Standard Enfamil ® Casein Casein Comparison Test DietControl Control Diet Nutrient Individual Ingredient to add g/kg g/kgg/kg g/kg Fiber: Cellulose 0.00 8.87 8.87 0 Vitamin Pre-Mix VitaminPre-Mix 0 5.50 10.00 0 Vitamin A (IU/kg) Vitamin A (IU/kg) 18259.25Vitamin E (IU/kg) Vitamin E (IU/kg) 0.00 Vitamin D (IU/kg) Vitamin D(IU/kg) 2724.89 Nicotinic Acid Niacin 0.0281 Pantothenic AcidCa-D-pantothenate 0.0225 B2 Riboflavin 0.0074 B1 Thiamine-HCL 0.0030 B6Pyridoxince-HCL 0.0017 Folic Acid Folic Acid 0.0000 Biotin Biotin 0.0001B12; Cyanocobalamin Vitamin B12 0.0000 K1 Pylloquinone 0.0005 Vitamin CAscorbic Acid 0.6570 Choline Choline Bitartrate 0.0 3.4307 2.00 0L-Carnitine L-Carnitine 0.1353 Taurine Taurine 0.4191 InositolM-Inositol 0.2768 Nucleotides Nucleotide Pre-mix 0.2761 (SponsorSupplied) Lutein Lactose-Lutein Pre-mix 32.8057 (Sponsor Supplied) BetaCarotene Beta Carotene 0.0009 Lactose Lactose, alpha 369.856Monohydrate, Plant EU # 2118720 (DYETS supplied) Glucose Glucose 14.7060Corn Starch: Corn Starch 247.59 211.2020 694.14 0 Sucrose Sucrose 50.00Total Target: 1000 1000 1000 1000

APPENDIX B

Finished Rodent Diets (Nutrient Composition) Modified Standard Enfamil ®Casein Casein Comparison Rat growth Infant Control Diet 2 Control Diet 3Diet 4 requirements Formula Modified Standard Enfamil ® (1995 NRC, TestDiet 1 Casein Casein Comparison per kg diet table 2-2) Test Diet ControlControl Diet g Protein 150 100.0 100.0 100.0 100.0 N 16.00 16.0 16.016.0 Lactose 367.28 367.25 0.00 507.83 CHO, total 625.79 567.62 646.68561.53 Fat, total 193.38 193.39 79.99 267.59 Fiber 12.85 10.00 10.0046.44 Moisture 51.00 50.93 69.00 46.98 Ash 27.18 37.40 34.96 29.41 g %Protein 10.00% 10.00% 10.00% 10.00% Lactose 36.73% 36.72% 0.00% 50.78%Fat 19.34% 19.34% 8.00% 26.76% Fiber  1.29%  1.00%  1.00%  4.64%Moisture  5.10%  5.09%  6.90%  4.70% Ash  2.72%  3.74%  3.50%  2.94%IU/kg Vitamin A (IU) 2,300 20283 20283 3680 62502 Vitamin E (IU) 27 103144.3 85.2 154.3 Vitamin D (IU) 1000 3154 3154 781 3281 mg/kg Niacin15.00 45.63 45.63 31.80 61.53 Pantothenate 10.00 30.66 30.66 14.80 36.87Riboflavin 3.00 10.22 10.22 5.04 12.31 Thiamin 4.00 5.97 5.97 5.39 4.98B6 (Pyridoxine) 6.00 6.00 6.00 7.76 6.00 g Folic Acid 1.00 1.00 1.001.82 1.00 Biotin 0.20 0.25 0.25 0.32 0.28 B12 0.05 0.05 0.05 0.03 0.05Vitamin K 1.00 1.00 1.00 0.94 1.00 Vitamin C 0.00 656.99 656.99 0.00874.06 mg/kg Choline 750 (or 2000 1411.8 1410.0 822 1635.805 of CholineBitartrate) gm/kg Sodium 0.5 1.713 1.713 1.213 1.489 Chloride 0.5 3.1762.653 1.867 3.721 Calcium 5 5.000 5.000 6.387 5.000 Phosphorus 3 3.0003.000 3.010 3.000 Potassium 3.6 5.427 5.427 4.042 7.098 Magnesium 0.50.500 0.500 0.595 0.537 Sulfur⁵ 0.013 0.446 0.469 0.000 mg/kg Chromium¹0.000 0.887 1.198 0.000 Copper 5 4.999 5.207 7.312 5.001 Fluoride¹ 0.0000.567 0.767 0.000 Iodine 0.15 1.287 1.285 0.140 1.436 Iron 35 73.16273.162 48.720 104.008 Manganese 10 9.999 9.999 11.980 9.998 Molybdenum0.15 0.150 0.149 0.079 0.150 Selenium 0.15 0.182 0.182 0.166 0.251 Zinc12 47.280 47.282 37.097 61.526 mg/kg L-Carnitine Not established 135.3135.3 172.37 Taurine Not established 419.12 419.12 392.10 M-Inositol Notestablished 276.8 276.8 433.12 Nucleotides Not established 276.1 276.1 0Lutein Not established 0.5 0.5 0 Beta Carotene Not established 0.9 0.9 0⁵Sulfur, Chromium and Fluoride are not required under NRC but arepresent in the certified mineral mix added to the control diets.

APPENDIX C

Selected Ingredient Specifications Spec DYETS 310113: Vitamin VitaminPremix Premix Lot # 0112-A Vitamin (mg/10 g) mg/g of mix Vitamin A(IU)4000 368 Vitamin E (IU) 75 8.52 Vitamin D (IU) 1000 78.1 Menadione 00.0000 Choline 0 0.0000 p-Aminobenzoic 0 0.0000 Inositol 0 0.0000 Niacin30 3.1800 Ca-D-pantothenate 16 1.4800 Riboflavin 6 0.5040 Thiamine-HCL 60.5390 Pyridoxine-HCL 7 0.7760 Folic Acid 2 0.1820 Biotin 0.3 0.0318Vitamin B12 0.05 0.0025 Pylloquinone 1.25 0.0944 Sucrose: qs to (mg)1000 1000 Mineral Mix Spec DYET #210050 Mineral Mineral Mix, Lot # Mix0112-B Ingredient Mineral (mg/35 g) mg/g of mix Calcium Carbonate (40.0%Ca) Calcium (Ca) 5000.0 151.0000 Potassium Phosphate, Monobasic (28.7%Phosphorous (P) 1995.0 50.8000 K, 22.8% P) Potassium Citrate - 1 H2O(36.2% K) Potassium (K) 354.8 96.00 Potassium Sulfate (44.9% K, 18.4% S)Sulfur (S) 300.0 11.20 Magnesium Oxide (60.3% Mg) Magnesium (Mg) 500.013.70 Sodium Chloride Sodium (Na) 1000.0 27.60 (39.3% Na, 60.7% Cl)Chloride (Cl) 1600.0 40.60 Cupric Carbonate (57.5% Cu) Copper (Cu) 6.000.1580 Potassium Iodate (59.3% I) Iodine (I) 0.20 0.00334 Ferric Citrate(17.4% Fe) Iron (Fe) 37.00 1.130 Manganese Carbonate (47.8% Mn)Manganese (Mn) 10.50 0.2860 Sodium Selenate (41.8% Se) Selenium (Se)0.20 0.0040 Zinc Carbonate (52.1% Zn) Zinc (Zn) 30.00 0.8790 Chromium KSulfate - 12 H2O (10.4% Cr) Chromium (Cr) 0.9625 0.0286 AmmoniumMolybdate - 4 H2O (54.3% Molybdenum 0.1511 0.00189 Mo) (Mo) SodiumSilicate (9.89% Si) 0.0414 0.0183 Lithium Chloride 0.0005 0.0012 BoricAcid 0.0023 0.000014 Sodium Fluoride (45.2% F) Fluoride (F) 1.00000.000066 Nickel Carbonate 0.0009 0.000026 Ammonium Vanadate 0.00020.000006 Sucrose 7.34 g 209.81 mg Product: Lactose Monohydrate g/kg of %of Nutrient product product Protein: 0.00 0.00% Fat: 0.00 0.00%Moisture: 48.3 4.83% Ash: 0.9 0.09% Lactose: 950.1 95.01% Fiber: 0.000.00% Product ID (name and Lot #): Casein, 80 Mesh, DYETS #400601, Lot #20017 g/kg of % of Nutrient product product Protein: 866 86.60% Fat: 121.20% Moisture: 87.3 8.73% Ash: 10.1 1.01% Lactose: 0 0.00% Fiber: 9.770.98% Minerals unit Sodium 31 mg/100 g Chloride 108 mg/100 g Calcium23.8 mg/100 g Phosphorus 674 mg/100 g Magnesium 0 mg/100 g

APPENDIX D

Analysis - Formulation A Sponsor: Building Block Nutritionals Product ID(name and Lot #): Formulation A g/100 g % of Nutrient of product productProtein: 13.60 13.60% Fat: 26.30 26.30% Moisture: 2.265 2.27% Ash: 3.1803.18% Fiber: 1.748 1.748% Lactose: 49.950 49.95% Total Carbohydrates54.600 54.60% Fat Breakdown % of Total Fat Fat Blend 26.3000 100.00%Carbohydrate Breakdown Lactose: 49.95 49.95% Glucose 2.00 2.00% Balanceof Carbs 2.65 2.65% Vitamins unit Vitamin A (Retinol) 2758.5000 IU/100 gVitamin E (DL-Į-tocopherol) 14.00 IU/100 g Vitamin D3 429.00 IU/100 gNiacin 6.2050 mg/100 g Pantothenate 4.1700 mg/100 g Riboflavin (B2)1.3900 mg/100 g Thiamin (B1) 0.8120 mg/100 g B6 (Pyridoxine) 0.4310mg/100 g Folic Acid 0.1035 mg/100 g Biotin 0.0346 mg/100 g B12 0.0056mg/100 g Vitamin K1 0.0744 mg/100 g Vitamin C 89.35 mg/100 g Choline(Choline Bitartrate) 0.1920  g/100 g Minerals unit Sodium 233 mg/100 gChloride 432 mg/100 g Calcium 558 mg/100 g Phosphorus 363.5 mg/100 gPotassium 682 mg/100 g Magnesium 59.55 mg/100 g Sulfur mg/100 g Chromiummg/100 g Copper 0.4515 mg/100 g Fluoride mg/100 g Iodine 0.1750 mg/100 gIron 9.9500 mg/100 g Manganese 0.1520 mg/100 g Molybdenum mg/100 gSelenium 0.0247 mg/100 g Zinc 6.4300 mg/100 g Additional Ingredientsunit L-Carnitine 18.4 mg/100 g Taurine 57 mg/100 g M-Inositol 37.65mg/100 g Nucleotides 37.55 mg/100 g Lutein 0.0696 mg/100 g Beta Carotene0.129 mg/100 g

TABLE 2A INDIVIDUAL TOTAL DIET CONSUMPTION Acclimation Period DietConsumption Day −6 Day −5 Day −4 Day −3 Day −2 Day −1

TABLE 2B INDIVIDUAL TOTAL DIET CONSUMPTION Acclimation Period DietConsumption Average 4.5 5.2 6.3 6.1 5.6 6.1 SD 0.7 0.8 1.2 0.9 0.7 0.7

TABLE 2C INDIVIDUAL TOTAL DIET CONSUMPTION Group 1(M); Week Week WeekWeek Total Food Week #s 1-4 #1 #2 #3 #4 Consumption Average 51.7 72.890.5 92.8 307.8 SD 5.55 6.67 5.73 8.77 21.44

TABLE 2D INDIVIDUAL TOTAL DIET CONSUMPTION Group 2(M); Animal Week WeekWeek Week Total Food Week #s 1-4 # #1 #2 #3 #4 Consumption Average 50.365.9 71.7 71.9 259.8 SD 3.30 5.58 6.69 10.18 24.72

TABLE 2E INDIVIDUAL TOTAL DIET CONSUMPTION Group 3(M); Week Week WeekWeek Total Food Week #s 1-4 #1 #2 #3 #4 Consumption Average⁶ 72.01 91.6899.36 109.74 372.79 SD¹ 3.70 8.83 6.48 7.80 21.31 ⁶The average andstandard deviation do not include Animal #1028.

TABLE 2F INDIVIDUAL TOTAL DIET CONSUMPTION Group 4(M); Week Week WeekWeek Total Food Week #s 1-4 #1 #2 #3 #4 Consumption Average 43.8 66.280.9 85.8 276.7 SD 4.59 4.74 3.54 6.08 14.18

TABLE 3A EXPERIMENTAL PER Group 1(M); Protein Efficiency Week #s 1-4Ratio Average 3.62 SD 0.28

TABLE 3B EXPERIMENTAL PER Group 2(M); Protein Efficiency Week #s 1-4Ratio Average 2.76 SD 0.11

TABLE 3C EXPERIMENTAL PER Group 3(M); Protein Efficiency Week #s 1-4Ratio Average 3.15⁷ SD 0.22 ⁷The average and standard deviation do notinclude Animal #1028.28one animal; which was found dead on Day 12

TABLE 3D EXPERIMENTAL PER Group 4(M); Protein Efficiency Week #s 1-4Ratio Average 3.37 SD 0.23

TABLE 4 INDIVIDUAL IN-LIFE OBSERVATIONS Acclimation Period Day ofOccurrence Animal #⁸ Ear Tag Observation Grade −6 −5 −4 −3 −2 −1 0 1001593 Active and healthy x x x Coat soiled, body, oily Slight x x Reducedfecal volume x x Coat soiled, body, oily Moderate x x 1011 594 Activeand healthy x x Soft feces x x Ano-genital staining x Coat soiled, body,oily Slight x x x x Reduced fecal volume x 1034 595 Active and healthy xSoft feces x Ano-genital staining x x Reduced fecal volume x x x Coatsoiled, body, oily Slight x x x x Coat soiled, body, oily Moderate x1012 596 Active and healthy x Ano-genital staining x Coat soiled, body,oily Slight x x x Coat soiled, body, oily Moderate x x — 597 Active andhealthy x x x Coat soiled, body, oily Slight x x x x Reduced fecalvolume x x Acclimation Period Day of Occurrence Animal #⁹ Ear TagObservation Grade −6 −5 −4 −3 −2 −1 0 — 598 Active and healthy x xReduced fecal volume x x x x x Coat soiled, body, oily Slight x x x x —599 Active and healthy x Soft feces x x x Coat soiled, body, oily Slightx x x x Reduced fecal volume x 1039 600 Active and healthy x x Reducedfecal volume x x x x x Coat soiled, body, oily Slight x x x x Soft fecesx x 1010 601 Active and healthy x Soft feces x x x x Coat soiled, body,oily Slight x x x x Reduced fecal volume x x x 1038 602 Active andhealthy x x x x Coat soiled, body, oily Slight x x x Reduced fecalvolume x x 1004 603 Active and healthy x x x Coat soiled, body, oilySlight x x x x Reduced fecal volume x Acclimation Period Animal Day ofOccurrence #¹⁰ Ear Tag Observation Grade −6 −5 −4 −3 −2 −1 0 1016 604Active and healthy x x x Soft feces x Diarrhea x Reduced fecal volume xx 1036 605 Active and healthy x x x Coat soiled, body, oily Slight x x xx Reduced fecal volume x x 1024 606 Active and healthy x x Coat soiled,body, oily Slight x x x x x Reduced fecal volume x x 1009 607 Active andhealthy x Diarrhea x x Ano-genital staining x x x x x Coat soiled, body,oily Slight x x x x Reduced fecal volume x x 1017 608 Active and healthyx x Coat soiled, body, oily Slight x x x x x Reduced fecal volume x x1025 609 Active and healthy x x Diarrhea x Coat soiled, body, oilySlight x x x x Reduced fecal volume x x Acclimation Period Animal Day ofOccurrence #¹¹ Ear Tag Observation Grade −6 −5 −4 −3 −2 −1 0 1014 610Active and healthy x x Diarrhea x x Coat soiled, body, oily Slight x x xReduced fecal volume x x Coat soiled, body, oily Moderate x x 1008 611Active and healthy x x x Coat soiled, body, oily Slight x x x x 1032 612Active and healthy x x Diarrhea x Coat soiled, body, oily Slight x xReduced fecal volume x Coat soiled, body, oily Moderate x x — 613 Activeand healthy x Diarrhea x x Ano-genital staining x Coat soiled, body,oily Slight x x x x Reduced fecal volume x 1018 614 Active and healthy xx Soft feces x Coat soiled, body, oily Slight x x x x x Reduced fecalvolume x x Acclimation Period Animal Day of Occurrence #¹² Ear TagObservation Grade −6 −5 −4 −3 −2 −1 0 1007 615 Active and healthy x x xCoat soiled, body, oily Slight x x Reduced fecal volume x x Coat soiled,body, oily Moderate x x 1040 616 Active and healthy x Ano-genitalstaining x Reduced fecal volume x x x Diarrhea x Coat soiled, body, oilySlight x x x x 1019 617 Active and healthy x x Reduced fecal volume x xCoat soiled, body, oily Slight x x x x 1023 618 Active and healthy xDiarrhea x Coat soiled, body, oily Slight x x x Reduced fecal volume xCoat soiled, body, oily Moderate x x 1031 619 Active and healthy x xReduced fecal volume x x x Coat soiled, body, oily Slight x x x xAcclimation Period Animal Day of Occurrence #¹³ Ear Tag ObservationGrade −6 −5 −4 −3 −2 −1 0 1006 620 Active and healthy x Diarrhea x xAno-genital staining x x Reduced fecal volume x x Coat soiled, body,oily Slight x x x Coat soiled, body, oily Moderate x — 621 Active andhealthy x Diarrhea x x Ano-genital staining x x Coat soiled, body, oilySlight x x x Coat soiled, body, oily Moderate x Reduced fecal volume x x1022 622 Active and healthy x x x Coat soiled, body, oily Slight x x x xReduced fecal volume x 1027 623 Active and healthy x x Reduced fecalvolume x x x Coat soiled, body, oily Slight x x x x 1029 624 Active andhealthy x Soft feces x x Coat soiled, body, oily Slight x x x x Reducedfecal volume x x Acclimation Period Animal Day of Occurrence #¹⁴ Ear TagObservation Grade −6 −5 −4 −3 −2 −1 0 1021 625 Active and healthy x xReduced fecal volume x x x Coat soiled, body, oily Slight x x x x 1026626 Active and healthy x Diarrhea x Ano-genital staining x Reduced fecalvolume x x x Coat soiled, body, oily Slight x x x x 1015 627 Active andhealthy x Ano-genital staining x x Diarrhea x Coat soiled, body, oilySlight x x x x Reduced fecal volume x 1013 628 Active and healthy xDiarrhea x x Coat soiled, body, oily Slight x x x x Reduced fecal volumex x 1020 629 Active and healthy x x x Coat soiled, body, oily Slight x xx x Acclimation Period Animal Day of Occurrence #¹⁵ Ear Tag ObservationGrade −6 −5 −4 −3 −2 −1 0 1002 630 Active and healthy x Diarrhea xReduced fecal volume x x x Coat soiled, body, oily Slight x x x x 1028631 Active and healthy x x x Coat soiled, body, oily Slight x x x xReduced fecal volume x x Soft feces x 1030 632 Active and healthy xAno-genital staining x x x Coat soiled, body, oily Slight x x Coatsoiled, body, oily Moderate x x x 1005 633 Active and healthy x Diarrheax Reduced fecal volume x x x Coat soiled, body, oily Slight x x x x 1037634 Active and healthy x x Coat soiled, body, oily Slight x x x x xActive and healthy x x x 1003 635 Coat soiled, body, oily Slight x Coatsoiled, body, oily Moderate x x x Reduced fecal volume x x AcclimationPeriod Animal Day of Occurrence #¹⁶ Ear Tag Observation Grade −6 −5 −4−3 −2 −1 0 1035 636 Active and healthy x Soft feces x x Coat soiled,body, oily Slight x x Coat soiled, body, oily Moderate x x 1033 637Active and healthy x Diarrhea x Reduced fecal volume x x x Coat soiled,body, oily Slight x x x x x — 638 Active and healthy x x Reduced fecalvolume x x x x Coat soiled, body, oily Slight x x x x Group 1 AnimalAnimal Day of Occurrence Numbe Sex Observation Grade 0 1 2 3 4 5 6 7 8 91 1 1 1 1 1001 M Reduced x x x x x x x x Coat Moderat x x x x soiled,Slight x x x Active and x x x x x x 1002 M Reduced x x Coat Slight x x xx Diarrhea x x Active and x x x x x x x x x Soft feces x 1003 M Reducedx x Coat Moderat x soiled, Slight x x Active and x x x x x x x x x x x1004 M Reduced x x x x x x Coat Slight x x x x x x x x x x Soft feces x1005 M Reduced x x x Coat Slight x x Active and x x x x x x x x x x xGroup 1 Animal Animal Day of Occurrence Numbe Sex Observation Grade 0 12 3 4 5 6 7 8 9 1 1 1 1 1 1006 M Reduced x Coat Moderat x x x Diarrhea xx Coat Slight x x x x x x x x x x x x Soft feces x 1007 M Reduced x x xx x x x x x Coat Moderat x x soiled, Slight x x Active and x x x x x x1008 M Coat Slight x Active and x x x x x x x x x x Reduced x x x x 1009M Reduced x x x x x x x Ano- x x x Coat Slight x x x x x x x x Activeand x x x x x x x 1010 M Reduced x x x x x x x Coat Slight x x x Activeand x x x x x x x x Group 1 Animal Day of Occurrence Animal SexObservation Grade 1 1 1 1 1 2 2 2 2 2 2 2 2 2 1001 M Reduced x x Ano- xActive and x x x x x x x Diarrhea x Soft feces x x x x 1002 M Soft fecesx x x x x x x x x x Ano- x Active and x x x x 1003 M Active and x x x xx x x x x x x x x x 1004 M Soft feces x x x x x x x x x x Coat Sligh x xActive and x x Reduced x 1005 M Active and x x x x x x x x x x x x x x1006 M Soft feces x x x x x x x x x Coat Sligh x x x x x x Ano- x Activeand x x x x x 1007 M Active and x x x x x x x x x x x x x Soft feces xGroup 1 Animal Animal Day of Occurrence Number Sex Observation 15 16 1718 19 20 21 22 23 24 25 26 27 28 1008 M Active and x x x x x x x x x x xReduced x x x 1009 M Active and x x x x x x x x x x x x x Soft feces x1010 M Active and x x x x x x x x x x Soft feces x Diarrhea x x x Group2 Day of Occurrence Animal Anima Observatio Grade 0 1 2 3 4 5 6 7 8 9 11 1 1 1 1011 M Coat Slight x x x Coat Moderat x x x x x x x x x x x x1012 M Coat Moderat x x x x x soiled, Extreme x x x x x x x x x xReduced x 1013 M Reduced x x Coat Slight x x x x x x x x x x x x x CoatModerat x x 1014 M Reduced x x Coat Moderat x x x x Coat Slight x x x xx x x x x x x 1015 M Reduced x Coat Slight x x x x x x x x x x x x x x x1016 M Reduced x x x x Active and x x x x x x x x x x x 1017 M Reduced xx Coat Slight x Coat Moderat x x x x x x x x x x x x x x Group 2 AnimalAnimal Day of Occurrence Numbe Sex Observation Grade 0 1 2 3 4 5 6 7 8 91 1 1 1 1 1018 M Reduced x Coat Slight x x x Coat Moderat x x x x x x xx x x x x 1019 M Reduced x Coat Slight x x x x x x x x x x x x x x x1020 M Coat Slight x x x x x x x x x Coat Moderat x x x x x x Group 2Day of Occurrence Animal Animal Observation Grade 1 1 1 1 1 2 2 2 2 2 22 2 2 1011 M Coat Slight x x Active x x x x x x x x x x x x 1012 M CoatModer x x soiled, Slight x x x x x x x x x x Active x x 1013 M CoatSlight x x Active x x x x x x x x x x x x 1014 M Coat Slight x x x x x xx x x Active x x x x x 1015 M Active x x x x x x x x x x x x x x 1016 MActive x x x x x x x x x x x x x x 1017 M Coat Moder x x Coat Slight x xx x x x x x x x x x 1018 M Coat Moder x x soiled, Slight x x x x x x xActive x x x x x 1019 M Coat Slight x x x x x x x Active x x x x x x x1020 M Coat Slight x x x x x x x x Active x x x x x x Group 3 AnimalAnimal Day of Occurrence Numbe Sex Observation Grade 0 1 2 3 4 5 6 7 8 91 1 1 1 1 1021 M Reduced x Coat Slight x x x x Active and x x x x x x xx x x x 1022 M Coat Slight x x x x x x x Active and x x x x x x x x 1023M Coat Moderat x x x soiled, Slight x x x x Active and x x x x x x x x1024 M Reduced x Coat Slight x x x Active and x x x x x x x x x x x x1025 M Reduced x Coat Slight x x Active and x x x x x x x x x x x x x1026 M Reduced x Coat Slight x x x x x x x Active and x x x x x x x x1027 M Reduced x Coat Slight x Active and x x x x x x x x x x x x x xGroup 3 Animal Animal Day of Occurrence Numbe Sex Observation Grade 0 12 3 4 5 6 7 8 9 1 1 1 1 1 1028 M Reduced x x x Coat Slight x x x x x x xActive and x x x x Dead 1029 M Reduced x Coat Slight x x Active and x xx x x x x x x x x x x 1030 M Coat Moderat x x x soiled, Slight x x x xActive and x x x x x x x x Group 3 Animal Animal Day of OccurrenceNumber Sex Observation 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1021 MActive and x x x x x x x x x x x x x x 1022 M Active and x x x x x x x xx x x x x x 1023 M Active and x x x x x x x x x x x x x x 1024 M Activeand x x x x x x x x x x x x x x 1025 M Active and x x x x x x x x x x xx x x 1026 M Active and x x x x x x x x x x x x x x 1027 M Active and xx x x x x x x x x x x x x 1029 M Active and x x x x x x x x x x x x x x1030 M Active and x x x x x x x x x x x x x x Group 4 Animal Animal Dayof Occurrence Numbe Sex Observation Grade 0 1 2 3 4 5 6 7 8 9 1 1 1 1 11031 M Reduced x x x Coat Slight x x x x Active and x x x x x x x x x xx 1032 M Coat Moderat x x x Reduced x x Coat Slight x x x x x x x x x xx x Diarrhea x Soft feces x x x x x x x Ano- x x x x x x 1033 M CoatSlight x x x x x x Active and x x x x Reduced x x x Ano- x x x x x xSoft feces x x x x 1034 M Coat Moderat x x x x x x x x x Reduced x x x xx Diarrhea x x Ano- x x x x x x x x Coat Slight x x x x x x Soft feces xx x x x 1035 M Coat Moderat x x x Reduced x x x x x x x x x x CoatSlight x x x x x x x x x x x x Diarrhea x x Ano- x x x x x x Soft fecesx 1036 M Reduced x Coat Slight x x x x x x x x Active and x x x x x xAno- x x x x Diarrhea x x Soft feces x x 1037 M Coat Slight x x x x x xx Reduced x x x x x x x Coat Moderat x x x x x x x x Ano- x Soft feces x1038 M Reduced x x x x x x x Coat Slight x x x x Diarrhea x Active and xx x x Soft feces x x Ano- x Group 4 Animal Animal Day of OccurrenceNumber Sex Observation Grade 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 1039 MReduced x x x x Coat soiled, Slight x x x x x x x x x x x x x x xDiarrhea x Soft feces x x x x x x Ano-genital x x x x x x 1040 M Reducedx x x x x x x Coat soiled, Slight x x x x x x x x x x Active and x x xSoft feces x x x x x Ano-genital x Group 4 Animal Day of OccurrenceAnimal Sex Observation Grade 1 1 1 1 1 2 2 2 2 2 2 2 2 2 1031 M Active xx x x x x x x x x x Soft feces x x x 1032 M Soft feces x x x x CoatSlight x x x x x x x x Ano- x x x x x Reduced x x x Active x x x x 1033M Soft feces x x x x x Coat Slight x x x x x Active x x x x x x x x x1034 M Soft feces x x x x x x x x x x x x x Coat Slight x x x x x x x xx x x x Ano- x x x x x Coat Modera x Diarrhea x x x x 1035 M Coat Slightx x x x x x x x Ano- x x Soft feces x Active x x x x x x 1036 M Reducedx Coat Slight x x x x x x x x x Active x x Soft feces x x Diarrhea x1037 M Soft feces x x Coat Modera x x soiled, Slight x x x x x x xActive x x x x x Soft feces x x x x x x x x x 1038 M Ano- x Diarrhea xActive x x x x 1039 M Soft feces x x x x x x x x x x x x Coat Slight x xx x x x Ano- x x Diarrhea x x 1040 M Soft feces x x x x x x x x x CoatSlight x x x x x x x Ano- x Coat Modera x ⁸Animals not assigned toindividual groups, prior to randomization were identified by their eartag ID number. Once selected for test, animals were assigned an animalnumber. ⁹Animals not assigned to individual groups, prior torandomization were identified by their ear tag ID number. Once selectedfor test, animals were assigned an animal number. ¹⁰Animals not assignedto individual groups, prior to randomization were identified by theirear tag ID number. Once selected for test, animals were assigned ananimal number. ¹¹Animals not assigned to individual groups, prior torandomization were identified by their ear tag ID number. Once selectedfor test, animals were assigned an animal number. ¹²Animals not assignedto individual groups, prior to randomization were identified by theirear tag ID number. Once selected for test, animals were assigned ananimal number. ¹³Animals not assigned to individual groups, prior torandomization were identified by their ear tag ID number. Once selectedfor test, animals were assigned an animal number. ¹⁴Animals not assignedto individual groups, prior to randomization were identified by theirear tag ID number. Once selected for test, animals were assigned ananimal number. ¹⁵Animals not assigned to individual groups, prior torandomization were identified by their ear tag ID number. Once selectedfor test, animals were assigned an animal number. ¹⁶Animals not assignedto individual groups, prior to randomization were identified by theirear tag ID number. Once selected for test, animals were assigned ananimal number.

APPENDIX B1: DIET ANALYSES RESULTS

Analytical Results Group 1 Group 2 Group 3 Group 3 Test Article ModifiedCasein Standard Casein Enfamil ® Comparison Analysis Unit Diet ControlDiet Control Diet Test Diet Protein % 9.92 9.90 10.04 9.88 (average)Moisture % 6.24 6.06 8.94 5.21 Ash % 2.56 2.58 2.57 2.54 Crude Fiber %0.312 0.526 0.514 0.129 Fat % 19.9 19.3 8 25.6 Lactose % 32.3 18.5 <0.134.4 Zinc PPM 38.5 54.0 45.1 57.8 Riboflavin MCG/G 8.64 10.1 5.79 6.36

Example 3. Clinical Study for the Growth and Safety Study ° FanExemplary Infant Formulator Healthy Term Infants

Protocol Synopsis

The purpose of this study is to demonstrate that this formulation meetsnutritional requirements and supports age appropriate growth of healthyterm infants.

Objectives:

The primary efficacy objective is to compare the growth of infantsrandomized to a commercially available term infant formula (BrandFormula) versus growth of infants randomized to two experimental infantformulas for term infants (FORMULA-001 w/OPN Formula and FORMULA-102 w/oOPN).

The secondary efficacy objective is to compare formula intake volumebetween formula groups.

The exploratory objective is to compare serum markers of inflammationbetween formula groups.

The primary safety objective is to compare the frequency of adverseevents (AEs) between the formula groups.

The secondary safety objective is to compare the gastrointestinaltolerance (stool composition, bowel movements, stool consistency, gas,fussiness, and ICQ scales) between formula groups.

Analyses between cohorts (Brand Formula, FORMULA-001 w/ OPN Formula, andFORMULA-102 w/o OPN) will occur separately depending on finalization ofGenerally Recognized as Safe (GRAS) approval of specific ingredients inFORMULA-001 w/ OPN Formula.

Study Design:

This study is a randomized, controlled, double-blind study of healthyterm formula-fed (FF) infants.

The first phase of the study, infants will receive either a new infantformula formulated for healthy term infants (FORMULA-001 w/ OPN Formula)or a commercially available infant formula for healthy term infants(Brand Formula) in a 1:1 ratio.

After completion of the first phase, in a second phase of the study,infants are randomized to receive either Brand Formula or FORMULA-102w/o OPN in a 1:8 ratio.

In both study arms, infants will consume the study formula for a totalof 16 weeks. Throughout the study, infant growth and tolerance to theformulas are assessed.

Criteria for Inclusion:

Infants are eligible to participate if they meet all of the followingconditions:

At Birth the Infant Must be:

-   -   1. Healthy, term (early term/no less than 37 weeks, 0 days        through late term/no greater than 41 weeks, 6 days), singleton        infant    -   2, Have a birth weight of ≥2500 grams        At the Time of the Baseline/Enrollment Visit, Infants Must be:    -   3. Designated as healthy by a physician    -   4. ≤14 days post-natal age (Date of Birth=Day 0)    -   5. Weight for age ≥5th and ≤95th percentile for age according to        sex-specific World Health Organization (WHO) growth charts for        infants and children ages 0 to 2 years of age    -   6. Length for age ≥5th and ≤95th percentile for age according to        sex-specific charts World Health Organization (WHO) growth        charts for infants and children ages 0 to 2 years of age    -   7. Head circumference for age ≥5th and ≤95th percentile for age        according to sex-specific World Health Organization (WHO) growth        charts for infants and children ages 0 to 2 years of age    -   8. Weight for length for age ≥5th and ≤95th percentile for age        according to sex-specific World Health Organization (WHO) growth        charts for infants and children ages 0 to 2 years of age    -   9. Exclusively consuming and tolerating a cow's milk infant        formula at time of enrollment; only infants whose parent(s) or        legal guardian(s) have decided to feed infant formula as the        sole source of nutrition are approached for potential study        enrollment    -   10. Have parent(s) or legal guardian(s) who agree to feed the        study formula to the study subject as his/her sole source of        nutrition for the duration of the study    -   11. Have parent(s) or legal guardian(s) who have read and        voluntarily signed an Informed Consent form approved by the        Institutional Review Board prior to any participation in the        study        Criteria for Exclusion:

Infants are ineligible if they have any of the following conditions thatare judged by a physician to interfere with the infant's normal growth,development, and/or tolerance to an infant formula:

-   -   1. Show evidence of anatomic and physiologic defects of the        respiratory tract, or other congenital defects (as determined by        the clinician)    -   2. Show evidence of chronic hepatic, gastrointestinal, renal,        cardiac, pulmonary, or neurological diseases    -   3. Have a maternal history with known adverse effects on the        fetus and/or the newborn infant, such as diabetes (gestational        diabetes is acceptable if infant's birth weight is <4300 g),        active tuberculosis, perinatal infection, or substance abuse    -   4. Have a family history of cow's milk protein        intolerance/allergy    -   5. Are an infant from a multiple birth (twin, triplet, etc.)        Investigational Product, Dose, and Mode of Administration:

Infants will consume ad libitum per day one of the following formulas:

Brand Formula: A commercially available infant formula for term infants;100 kcal/5 fl. oz, 2 g protein/100 kcal (Enfamil Infant 0-12 months byMead Johnson Nutrition, LLC)

FORMULA-001 w/ OPN Formula: An infant formula for term infantscontaining alpha-lactalbumin enriched whey, OPO Sn-2 oil, osteopontin,lactoferrin, pre-biotics (PD, FOS, GOS), lutein, microencapsulatedDHA/ARA; 100 kcal/5 fl. oz, 2.2 g protein/100 kcal (Manufactured byBuilding Block Nutritionals, LLC)

FORMULA-102 w/o OPN: An infant formula for term infants containingalpha-lactalbumin enriched whey, OPO Sn-2 oil, lactoferrin, pre-biotics(FOS, GOS), lutein, DHA/ARA; 100 kcal/5 fl. oz,

2.5 g protein/100 kcal (Manufactured by Building Block Nutritionals,LLC)

Primary Efficacy and Safety Evaluations:

Weight gain velocity (g/d)

Adverse Events are collected throughout the 16-week study

Statistical Methods:

For phase one of the study, sample size estimation is based on a testfor non-inferiority between Brand Formula and FORMULA-001 w/ OPNFormula. The criterion for non-inferiority in weight gain is that thedifference in the two formula-fed groups' (Brand Formula and B) meanweight gain velocity (g/d) is significantly less than 3 g/d. Assuming astandard deviation in weight gain of 5.6 g/d (Nelson et al., 1989) and80% power, 90 subjects per group (180 subjects total) are sufficient todemonstrate non-inferiority (one sided alpha=0.025). Assuming a 25%attrition rate, a total 256 subjects are enrolled in the Brand Formulaand FORMULA-001 w/ OPN Formula groups.

For phase two of the study, sample size estimation is based on theprimary endpoint, weight gain velocity (g/d) over a 16-week studyperiod. Weight gain velocity are compared between Brand Formula andFORMULA-102 w/o OPN using a non-inferiority margin of 3 g/d. A blindedinterim analysis of 81 subjects who completed 16 weeks of the study wasperformed in phase one of the study to estimate the standard deviationof weight gain. Based on this analysis, it is assumed that the standarddeviation in weight gain velocity is 6.0 g/d.

Assuming this standard deviation in weight gain of 6.0 g/d andapproximately 90% power, approximately 168 subjects (104 in the BrandFormula group and 64 in the FORMULA-102 w/o OPN group) are sufficient todemonstrate non-inferiority (one-sided alpha=0.025). Assuming a 25%attrition rate, a total of approximately 96 subjects are enrolled inphase two.

The plan is to use the 129 subjects randomized to Brand Formula in thefirst phase of the study, assuming a 25% attrition rate and 96 subjectsmeet the Per Protocol population criteria. This data has and will remainblinded through the enrollment of the study. In phase two of the study,infants are randomized to Brand Formula or FORMULA-102 w/o OPN in a 1:8ratio. Assuming a 25% attrition rate and to obtain approximately 90%power, approximately 10 subjects randomized to Brand Formula and 86subjects randomized to FORMULA-102 w/o OPN are enrolled in phase two ofthe study. With the addition of the 129 subjects from phase one of thestudy, there are approximately a total of 139 subjects enrolled in theBrand Formula group and 86 subjects enrolled in the FORMULA-102 w/o OPNgroup. Infants are stratified by sex to achieve balance of males andfemales within each formula group.

LIST OF APPENDICES

Appendix 1A—Anthropometry Data Collection Procedures

Appendix 1B—Formula Composition

Appendix 1C—Formula Ingredients

Appendix 1F—Standardized Definitions for Common Adverse Events

Appendix 1G—Formula Preparation Instructions

List of Abbreviations

-   -   AE Adverse event    -   ARA Arachidonic acid    -   BBN Building Block Nutritionals, LLC    -   bLF bovine lactoferrin    -   CFR Code of Federal Regulations    -   CI confidence interval    -   Cm centimeter    -   CRF Case report form    -   CRO Clinical research organization    -   CSA Clinical study agreement    -   CSR Clinical study report    -   DHA Docosahexaenoic acid    -   eCRF Electronic case report form    -   FDA Food and Drug Administration    -   FF formula-fed    -   fl oz fluid ounce    -   Formula A Experimental Formula A (Building Block Nutritionals,        LLC)    -   Formula B Commercially Available Milk Infant Formula (Enfamil        Infant 0-12 months)    -   Formula C Experimental Formula C (Building Block Nutritionals,        LLC)    -   FOS Fructo-oligosaccharide    -   g gram    -   GCP Good Clinical Practice    -   GERD Gastroesophageal Reflux Disease    -   GI Gastrointestinal    -   GOS Galacto-oligosaccharide    -   GRAS Generally recognized as safe    -   HM Human milk    -   HMO Human milk oligosaccharide    -   ICF Informed Consent Form    -   ICQ Infant Characteristics Questionnaire    -   IEC Independent ethics committee    -   IP Investigational product    -   IRB Institutional Review Board    -   ITT Intent to treat    -   kcal kilocalorie    -   kg kilogram    -   L liter    -   LCPFUA long chain polyunstaturated fatty acid    -   LOS lactulose    -   mcg microgram    -   MedDRA Medical Dictionary for Drug Regulatory Affairs    -   mg milligram    -   OFC occipital frontal circumference    -   OPN Osteopontin    -   oz ounce    -   PP Per protocol    -   PWD Powder    -   RTSM Randomization and Trial Supply Management    -   SAE Serious adverse event    -   SDV Source document verification

STUDY FLOWCHART Study Visit 1* 2* 3* 4 5* 6 7* 8 9* Study Day 15 ± 3 30± 3 45 ± 3 60 ± 3 75 ± 3 90 ± 3 105 ± 3 120 ± 3 0 days days days daysdays days days days Informed consent X Inclusion/Exclusion criteria XDemography X Randomization X Infant feeding history X Physical exam XMedical history X Maternal smoking history X Anthropometry¹ X X X X X XStool Characteristics and X X X X X X X X X Tolerance QuestionnaireInfant Characteristics X X X X X X Questionnaire (ICQ) 3-dayFormula/Diet Record² X X X X X X Blood Collection³ X Dispense stoolcollection kit⁴ X Stool collection⁴ X Telephone contact⁵ X X X XConcomitant medications X X X X X X X X X Adverse events X X X X X X X XX Dispense study formula X X X X X Collect unused study formula XColumns with a “*” indicate visit occurs at study site ¹Anthropometryincludes assessment of weight, length, and head circumference (seeAppendix A for procedure details). ²Initial 3-day Formula/Diet Recordare recorded for 3 days following the first study visit. Remainder of3-day Formula/Diet Records are recorded for 3 days prior to eachsubsequent scheduled study visit. ³Blood collection to assess markers ofinflammation (tumor necrosis factor-alpha, interleukin 2, 4, 5, 6, 8,10, 12, 13, & 17; interleukin 2 receptor, interleukin 1 beta, andinterferon gamma). ⁴Stool collection to assess stool composition. Stoolcollection supplies are distributed to parents at Visit 7 for collectionof all stools in the 3 days just before Visit 9. The stool collectionkit is returned at Visit 9. ⁵Initial telephone contact will occur 3 daysafter enrollment to check compliance with study feeding and inquireabout subject well-being. Remainder of telephone contacts will occurmid-way between clinic visits. Telephone contact notes are recorded inthe study subject's medical record. In the event a 3-day telephonecontact falls on a holiday or weekend, the contact are made on the nextavailable business day.Clinical Study Background Information and Rationale

If an infant cannot be breastfed, the American Academy of Pediatricsrecommends infant formula as the next best feeding alternative. Thisstudy is designed to evaluate the ability of FORMULA-001 w/ osteopontin(OPN) and FORMULA-102 w/o OPN to support age appropriate growth inhealthy term infants.

Objectives

Primary Efficacy Objective:

Compare the growth of infants randomized to a commercially availableterm infant formula (Brand Formula) versus growth of infants randomizedto the experimental infant formula for term infants (FORMULA-001 w/ OPNor FORMULA-102 w/o OPN).

Secondary Efficacy Objective:

Compare the formula intake volume between the formula groups.

Exploratory Objective:

Compare the markers of inflammation (tumor necrosis factor-alpha,interleukin 2, 4, 5, 6, 8, 10, 12, 13, & 17; interleukin 2 receptor,interleukin 1 beta, and interferon gamma) between the formula groups.

Primary Safety Objective:

To compare the frequency of adverse events (AEs) between the formulagroups.

Secondary Safety Objective:

To compare the gastrointestinal tolerance (stool composition, bowelmovements, stool consistency, gas, fussiness, and ICQ scales) betweenthe formula groups.

Study Design

Approximate Duration of Subject Participation

Subjects participate in the study for 16 weeks.

Approximate Number of Subjects

In phase one, approximately 256 healthy term infants (128 per group, 64per gender per group) are enrolled to complete a minimum of 180evaluable infants (90 per group, 45 per gender per group).

In phase two, approximately 96 healthy term infants (10 in the BrandFormula group and 86 in the FORMULA-102 w/o OPN group are enrolled. The129 subjects randomized to Brand Formula in the phase one of the studyare combined with the Brand Formula subjects in phase two to have aminimum of 139 infants in Brand Formula and 86 in FORMULA-102 w/o OPN.Infants are stratified by sex to achieve balance of males and femaleswithin each formula group.

Inclusion Criteria

Infants are eligible to participate if they meet all of the followingconditions. At birth the infant must be:

-   -   1. Healthy, term (no less than 37 weeks, 0 days and no greater        than 42 weeks, 0 days), singleton infant    -   2. Have a birth weight of ≥2500 grams

At the time of the baseline/enrollment visit, infants must be:

-   -   3. Designated as healthy by a physician    -   4. ≤14 days post-natal age (Date of Birth=Day 0)    -   5. Weight for age ≥5th and ≤95th percentile for age according to        World Health Organization (WHO) growth charts for infants and        children ages 0 to 2 years of age    -   6. Length for age ≥5th and ≤95th percentile for age according to        World Health Organization (WHO) growth charts for infants and        children ages 0 to 2 years of age    -   7. Head circumference for age ≥5th and ≤95th percentile for age        according to World Health Organization (WHO) growth charts for        infants and children ages 0 to 2 years of age    -   8. Weight for length for age ≥5th and ≤95th percentile for age        according to World Health Organization (WHO) growth charts for        infants and children ages 0 to 2 years of age    -   9. Exclusively consuming and tolerating a cow's milk infant        formula at time of enrollment; only infants whose parent(s) or        legal guardian(s) have decided to feed infant formula as sole        source of nutrition are approached for potential study        enrollment    -   10. Have parent(s) or legal guardian(s) who agree to feed the        study formula as the sole source of nutrition for the duration        of the study    -   11. Have parent(s) or legal guardian(s) who have read and        voluntarily signed an Informed Consent form approved by the        Institutional Review Board prior to any participation in the        study.    -   12. Infants may be considered for enrollment again with a new        baseline evaluation.        Exclusion Criteria

Infants are ineligible if they have any of the following conditions thatare judged by a physician to interfere with the infant's normal growth,development, and/or tolerance to an infant formula:

-   -   1. Show evidence of anatomic and physiologic defects of the        respiratory tract, or other congenital defects (as determined by        the clinician)    -   2. Show evidence of chronic hepatic, gastrointestinal, renal,        cardiac, pulmonary, or neurological diseases    -   3. Have a maternal history with known adverse effects on the        fetus and/or the newborn infant, such as diabetes (gestational        diabetes is acceptable if infant's birth weight is <4300 g),        active tuberculosis, perinatal infection, or substance abuse    -   4. Have a family history of cow's milk protein        intolerance/allergy    -   5. Are an infant from a multiple birth (twin, triplet, etc.)        Prior and Concomitant Medication and Treatment

Infants who were previously breastfed can be enrolled provided they havediscontinued breastfeeding at study entry, and parents agree that theyhave voluntarily chosen to exclusively formula-feed the study subjectduring the study. If formula-fed, infants must be currently receivingand tolerating cow's milk formula. At each study visit, site personnelwill interview parent(s)/guardian(s) to obtain information about allconcomitant therapy that was administered since the previous studyvisit. Concomitant medications include prescription medications,over-the-counter medications, and herbal supplements. Routine childhoodimmunizations will not be recorded as concomitant medications. Thisinformation is recorded in the subject's medical record. If the infantwas administered medication or treatment for a condition that may havean effect on the infants' growth and formula tolerance, the Investigatoror medical staff must assess the potential medical implications todetermine whether the study subject remains eligible to continue in thestudy. Use of an investigational product (i.e., therapeutic drug orvaccine) during a patient's participation in the study is prohibited.Participation in an observational ornon-pharmaceutical/non-interventional trial (i.e. device trial) isallowed.

If a study subject was fed a formula other than the assigned studyformula, this variation from protocol must be noted on the ProtocolDeviation Log.

Procedures

Screening

Each infant is screened for all inclusion and exclusion criteria. If aninfant complies with all inclusion and exclusion criteria and theparent(s)/guardian(s) sign the IRB-approved ICF, the infant israndomized to receive a study formula and assigned a unique subjectnumber. If the infant does not comply with one or more of the inclusionor exclusion criteria, the infant is defined as a screen failure.

Study Visit Procedures

Visit 1 (Day 0)

-   -   Informed consent process    -   Inclusion/Exclusion criteria    -   Demography    -   Randomization    -   Infant feeding history    -   Physical exam    -   Medical history    -   Maternal smoking history    -   Anthropometry (see Appendix 1A for data collection procedures)    -   Stool Characteristics and Tolerance Questionnaire    -   Infant Characteristics Questionnaire (ICQ)    -   3-day Formula/Diet Record    -   Telephone contact    -   Medications    -   Adverse events    -   Dispensing of study formula

Visit 2 (Day 15±3 Days)

-   -   Medical History    -   Anthropometry    -   Stool Characteristics and Tolerance Questionnaire    -   Infant Characteristics Questionnaire    -   3-day Formula/Diet Record    -   Medication    -   Adverse events    -   Dispensing of study formula

Visit 3 (Day 30±3 Days)

-   -   Medical history    -   Anthropometry    -   Stool Characteristics and Tolerance Questionnaire    -   Infant Characteristics Questionnaire    -   3-day Formula/Diet Record    -   Medication    -   Adverse events    -   Dispensing of study formula

Visit 4: Telephone Contact (Day 45±3 Days)

-   -   Stool Characteristics and Tolerance Questionnaire    -   Medication    -   Adverse events

Visit 5 (Day 60±3 Days)

-   -   Medical history    -   Anthropometry    -   Stool Characteristics and Tolerance Questionnaire    -   Infant Characteristics Questionnaire    -   3-day Formula/Diet Record    -   Medication    -   Adverse event    -   Dispensing of study formula

Visit 6: Telephone Contact (Day 75±3 Days)

-   -   Stool Characteristics and Tolerance Questionnaire    -   Medication    -   Adverse events

Visit 7 (Day 90±3 Days)

-   -   Medical history    -   Anthropometry    -   Stool Characteristics and Tolerance Questionnaire    -   Infant Characteristics Questionnaire    -   3-day Formula/Diet Record    -   Dispense stool collection kit    -   Medication    -   Adverse events    -   Dispensing of study formula

Visit 8: Telephone Contact (Day 105±3 Days)

-   -   Stool Characteristics and Tolerance Questionnaire    -   Medication    -   Adverse events

Visit 9 (Day 120±3 Days)

-   -   Medical history    -   Anthropometry    -   Stool Characteristics and Tolerance Questionnaire    -   Infant Characteristics Questionnaire    -   3-day Formula/Diet Record    -   Blood Collection    -   Stool collection    -   Medication    -   Adverse events    -   Collection of all unused/partially used study formula        Investigational Product and Administration        Study Formulas

Infants will consume ad libitum per day one of the following:

-   -   1. Brand Formula: A commercially available infant formula for        term infants; 100 kcal/5 fl. oz,    -   2 g protein/100 kcal (Enfamil Infant 0-12 months by Mead Johnson        Nutrition, LLC)    -   2. FORMULA-001 w/ OPN: An infant formula for term infants        containing alpha-lactalbumin    -   enriched whey, OPO Sn-2 oil, osteopontin, lactoferrin,        pre-biotics (PD, GOS, FOS), lutein, microencapsulated DHA/ARA;        100 kcal/5 fl. oz, 2.2 g protein/100 kcal (Manufactured by        Building Block Nutritionals, LLC)    -   3. FORMULA-102 w/o OPN: An infant formula for term infants        containing alpha-lactalbumin enriched whey, Sn-2 oil,        lactoferrin, pre-biotics (GOS, FOS), lutein, DHA/ARA; 100 kcal/5        fl. oz, 2.5 g protein/100 kcal (Manufactured by Building Block        Nutritionals, LLC)

See Appendix 1B for details of formula nutrient composition and Appendix1C for formula ingredients.

Type and Amount

Each infant will consume either Brand Formula, FORMULA-001 w/ OPN, orFORMULA-102 w/o OPN ad libitum for 16 weeks. Parent(s) or guardian(s)are discouraged from feeding their infant any foods other than theassigned study formula.

Administration

The study formula is provided in powder form. Each of the infantformulas are packaged in composite cans. Cans are labeled with a uniqueclinical product number to mask the identity of each clinical product.Study personnel will not be aware of the identity of the products.Nutrient and stability testing are conducted to ensure that each formulameets strict quality requirements for release.

Instructions for mixing the formula to 20 kcal/oz are given to theparent(s)/guardian(s).

Formula Storage by Investigator

Formula are labeled for clinical trial use only and kept dry, protectedfrom sunlight, and at room temperature (60-85° F., 16-29° C.). ThePrincipal Investigator is responsible for keeping all unassigned andreturned formula in a locked storage room with controlled staff access.

Formula Storage by Parent/Guardian

The parent(s)/guardian(s) are instructed to handle formula with cleanhands. Prior to opening, the can should be cleaned. Formula may beconsumed at room temperature. The parent(s)/guardian(s) are instructedto never microwave or freeze formula. Prepared formula may be warmed ina bowl of warm water. Parents are instructed that prepared formula notconsumed by the infant can be stored in the refrigerator for no morethan 24 hours, and then should be thrown away.

Parents are instructed to return all unopened cans of formula at thecompletion of the study.

Subject Compliance

Compliance with study feedings is monitored approximately every twoweeks throughout the study. A standard set of interview questions isadministered at each clinic visit and during telephone follow-up betweenclinic visits to inquire about consumption of study formula and allother feedings including other formulas.

Safety

Safety assessments will involve the monitoring and recording of all AEsand serious adverse events (SAEs), stool composition, gastrointestinaltolerance, periodic anthropometric measurements, and physicalassessments. Additional safety evaluations may be performed whenmedically indicated in the opinion of the Investigator.

Efficacy

a. Primary Efficacy Endpoint

Mean daily weight gain (g/d) over 16 weeks.

b. Secondary Efficacy Endpoints

Anthropometric measurements (head circumference gain velocity, lengthgain velocity) and Z-scores (weight for age, length for age, weight forlength for age, head circumference for age)

Formula intake volume

c. Exploratory Endpoint

Markers of inflammation (tumor necrosis factor-alpha, interleukin 2, 4,5, 6, 8, 10, 12, 13, & 17; interleukin 2 receptor, interleukin 1 beta,and interferon gamma).

Laboratory Determinations

Central laboratories are used for all laboratory determinations unless aspecial test or emergency testing is required. The central laboratoriesthat have been contracted to perform these tasks adhere to Good ClinicalPractices and will provide supplies and shipping materials for alllaboratory determinations. Refer to the central laboratory manual(s) foradditional information.

d. Biological Samples

A single blood sample (1.0 milliliters) is collected from each subjectvia heel stick at the last study visit (visit 9) to assess markers ofinflammation (tumor necrosis factor-alpha, interleukin 2, 4, 5, 6, 8,10, 12, 13, & 17; interleukin 2 receptor, interleukin 1 beta, andinterferon gamma). Stool samples will also be collected at the laststudy visit (visit 9) to assess stool composition (soap fatty acids).

Biological samples are used exclusively for the purposes outlined inthis protocol and for no other purpose.

Statistics

Statistical Methods

Analyses between cohorts (Brand Formula, FORMULA-001 w/ OPN, andFORMULA-102 w/o OPN) will occur separately depending on finalization ofGenerally Recognized as Safe (GRAS) approval of specific ingredients inFORMULA-001 w/ OPN formula.

Primary Efficacy Endpoint

The primary efficacy endpoint, mean daily weight gain (g/d) over a16-week study period, are compared between formula groups by thecalculation of the 95% two-sided confidence interval on the differencebetween the two means. Non-inferiority is determined if the lower limitof the two-sided 95% CI for the formula difference is greater than −3,assuming a non-inferiority margin of 3 mg/d.

Infant growth will also be descriptively summarized on the basis of thefollowing sex-specific z-scores based on World Health Organizationgrowth charts for infants and children ages 0 to 2 years of age:weight-for age, weight-for-length, length-for-age, and headcircumference-for-age z-scores. For each subject, a line listing of allraw measures of weight, length, head circumference, and all z-scores(weight-for-age z-score, length-for-age z-score, weight-for-lengthz-score, and head circumference-for-age z-score) is provided.Descriptive statistics are used to summarize weight (kg), length (cm),and head circumference (cm) and all z-score data (weight-for age,weight-for-length, length-for-age, and head circumference-for-age) byformula group for each visit. A test for non-inferiority will also beperformed for length gain (cm/d) velocity and head circumference gain(cm/d) velocity.

Safety Endpoints

A line listing of each subject with an adverse event is generated. Atthe group level, the number and percentage of subjects having each AEare summarized for each formula group. Secondary endpoints includingstool characteristics, GI tolerance, and infant characteristics aresummarized using descriptive statistics and qualitatively compared toage appropriate reference values when appropriate.

General Methods

Continuous variables are summarized using the appropriate descriptivestatistics: n, mean, standard deviation, median, minimum, and maximum.The geometric mean is presented for log-transformed variables. Frequencyand percentage of observed values are reported for categorical measures.A line listing of all data, sorted by subject and when appropriate bytime, is generated.

Analysis Populations

Intent to Treat (ITT): Subjects who are randomized to one of the formulafeeding groups.

Per Protocol (PP): A subset of the ITT population. It will consist ofall subjects who complete the feeding protocol without major protocolviolations and who consume a single non-study formula feeding no morethan 10 times during the duration of 16-week study as documented on theOther Than Formula Feeding Log. Additionally, subjects who consume morethan 3 complete days of non-study formula, defined as greater than 50%of the number of feedings in a 24-hour period from non-study formula,will also be excluded from the PP population.

Safety Population: The safety population is comprised of any subjectswho are randomized and consume at least one feeding of the assignedformula.

Classification into ITT or PP populations is conducted prior to thedatabase lock. All listings are provided for the ITT population. Aseparate listing is included on the set of subjects who are randomizedbut never take any feeding formula before discontinuing from the study.

Since this study has a primary aim at demonstrating non-inferiority, thePP population will represent the primary analysis population to evaluatethe treatment groups in terms of “efficacy”. All clinical outcomes(primary and secondary) are subject to analyses using both the PP andITT population.

Statistical Power and Sample Size Considerations

In phase one, assuming a standard deviation in weight gain of 5.6 g/d(Nelson et al., 1989) and 80% power, 90 subjects per group (180 total)is sufficient to demonstrate non-inferiority (one sided alpha=0.025).Assuming a 25% attrition rate, a total of 256 subjects are enrolled inthis trial. Within each formula group, infants are balanced by sex(equal number of males and females in each formula group). At theconclusion of the study, a post-hoc power analysis on weight gain isconducted.

In phase two, the sample size for this study is based on anon-inferiority test comparing weight gain velocity between BrandFormula and FORMULA-102 w/o OPN at Week 16. A non-inferiority margin of3 g/d is set for the difference in weight gain for the two formula-fedgroups (FORMULA-001 w/ OPN and FORMULA-102 w/o OPN).

A blinded interim analysis of 81 subjects who completed 16 weeks of thestudy was performed in phase one of the study to estimate the standarddeviation of weight gain. Based on this analysis, it is assumed that thestandard deviation in weight gain is 6.0 g/d. Assuming this standarddeviation in weight gain of 6.0 g/d and approximately 90% power,approximately 168 (104 in the Brand Formula group and 64 in theFORMULA-102 w/o OPN group) is sufficient to demonstrate non-inferiority(one-sided alpha=0.025). Assuming a 25% attrition rate, approximately atotal of 96 subjects are enrolled in phase two of this trial.

The plan is to use the 129 subjects randomized to Brand Formula in phaseone of the study, assuming a 25% attrition rate and 96 subjects meet thePer Protocol population criteria. This data has and will remain blindedthrough the enrollment of phase two of the study. In phase two of thestudy infants are randomized to Brand Formula or FORMULA-102 w/o OPN ina 1:8 ratio. Assuming a 25% attrition rate and to obtain approximately90% power, approximately 10 subjects randomized to Brand Formula and 86subjects randomized to FORMULA-102 w/o OPN are enrolled in phase two ofthe study. With the addition of the 129 subjects from phase one of thestudy, there are approximately a total of 139 subjects enrolled in theBrand Formula group and 86 subjects enrolled in the FORMULA-102 w/o OPNgroup. Infants are stratified by sex to achieve balance of males andfemales within each formula group.

Interim Analyses and Data Monitoring

In phase one, an interim analysis is conducted in a blinded manner when128 infants (50% of the total goal sample size) had enrolled andcompleted Visit 5. Weight gain velocity (g/d) for all infants werereported descriptively (minimum, maximum, mean, median, standarddeviation, first and third quartiles) for the following time intervals:enrollment to Visit 3, enrollment to Visit 5, Visit 3 to Visit 5. Thepurpose of the interim analysis was to determine whether or not theassumed standard deviation in weight gain velocity (5.6 g/d) based onreference data by Nelson et al., 1989, was appropriate for our studypopulation. No unblinding or inferential statistics are performed at theinterim; as such, no alpha spending procedures were required.

An interim analysis will not be performed for phase two of the study.

Subject Identification

Subjects are randomized and assigned a unique subject number. A subjectnumber will never be reassigned or reused for any reason. TheInvestigator will maintain a master log linking the subject number tothe subject's name. The Investigator will follow all applicable privacylaws in order to protect a subject's privacy and confidentiality.Information that could identify a subject is masked on study material.

Randomization

Formula-fed infants are randomly allocated to one of the three studyformulas (FORMULA-001 w/OPN, Brand Formula, and FORMULA-102 w/o OPN) viaRTSM (Randomization and Trial Supply Management) System. Randomizationis blocked by formula group and stratified by infant sex to achievebalance of males and females in each formula group.

Adverse Events

Definitions

An adverse event (AE) is any untoward, undesired, or unplanned event inthe form of signs, symptoms, disease, or laboratory or physiologicobservations occurring in a person administered an investigationalproduct in a clinical study. The event does not need to be causallyrelated to an investigational product or participation in the clinicalstudy. Any illness that a study subject develops during the study mustbe recorded on the AE case report form. Whenever possible, an illnessshould be recorded as a diagnosis rather than a series of symptoms.

Standardized definitions for stooling, spit-up, and crying (agreed uponby the Investigators and Medical Monitor; see Appendix 1F) are used toreport such symptoms.

All AEs must be assigned one of the following intensity scores:

-   -   Mild: Transient or mild discomfort (<48 hours); no medical        intervention/therapy required    -   Moderate: Mild to moderate limitation in activity, some        assistance may be needed; no or minimal medical        intervention/therapy required    -   Severe: Marked limitation in activity, some assistance usually        required; medical intervention/therapy required, hospitalization        possible    -   Serious: please see section 19.0.

All AEs must be assigned causality. The site PI or his/her designee willmake a determination about the causality or relatedness of an AE to theinvestigational product (i.e. study formula) using the followingcategories:

Related: An adverse event (AE) that has a clear temporal associationwith investigational product administration (e.g., within 24 hours) andthere is clear evidence of a causal relationship between theinvestigational product and the event.

Possibly Related: An AE with a temporal association with theinvestigational product, but other etiologies are possible. There is areasonable possibility that the investigational product caused theevent.

Unlikely Related: An AE with a temporal association with theinvestigational product, but other etiologies are more likely.Relatedness to the investigational product cannot definitely be ruledout, but there is less probability that the investigational productcaused the event.

Not Related: An AE with no temporal association with the investigationalproduct or one clearly related to other etiologies such as concomitantmedications or conditions, or the subject's known clinical state.

As a guideline for determining if an adverse event is related to theinvestigational product (investigational product related), the followingquestions should be considered:

Does a reasonable causal relationship exist between the AE and theinvestigational product based on clinical judgment and knowledge of thetreatment?

Is there a temporal relationship between the investigational product andthe appearance of the AE?

Is there biologic plausibility for a relationship between the AE and theinvestigational product?

Does the subject have an underlying medical condition or is the subjecttaking concomitant therapies or medications that could contribute to theAE?

Where applicable, does the AE abate on discontinuation of theinvestigational product (dechallenge)?

Where applicable, does the AE reappear on repeat exposure to theinvestigational product (rechallenge)?

A protocol-related adverse event is an AE occurring during a clinicalstudy that is not related to the investigational product, but isconsidered by the Investigator or the Medical Monitor (or designee) tobe related to the research conditions, (i.e., related to the fact that asubject is participating in the study).

Serious Adverse Events

A serious adverse event (SAE) is defined as an AE that:

Results in Death

Is life-threatening, i.e., the subject was, in the opinion of theInvestigator, at immediate risk of death from the event as it occurred(it does not include an event that, had it occurred in a more severeform, might have caused death)

Results in a significant, persistent or permanent change, impairment,damage, or disruption in the subject's body function/structure, physicalactivities, and/or quality of life

Requires in-subject hospitalization or prolongs hospitalization

Is another medically significant event that, based upon appropriatemedical judgment, may jeopardize the subject and may require medical orsurgical intervention to prevent one of the outcomes listed above (e.g.,allergic bronchospasm requiring intensive treatment in an emergencydepartment or home, blood dyscrasias, or convulsions that do not resultin hospitalization, or the development of drug dependency or drug abuse)

Adverse Event and Serious Adverse Event Recording and Reporting

Determination of AEs should be based on the signs or symptoms detectedduring the physical examination and on clinical evaluation of thesubject. Adverse events (AEs) are coded using the Medical Dictionary forDrug Regulatory Affairs (MedDRA).

AEs and SAEs are collected from the signing of the informed consent formto the end of study visit 9. The Investigator will instruct the subjectto report AEs and SAEs during this time period.

During the time period specified above, the Investigator will:

Record all AEs and SAEs in the subject's medical record.

Record all AEs, SAEs, and the treatment of the AE/SAE on a case reportform.

Report all SAEs to the Study Sponsor as directed and to the IRB asappropriate.

An AE/SAE's causal relationship to the product has no bearing on itsreportability. The Investigator must follow up on all AEs and SAEs untilthe events have subsided, until values have returned to baseline, or, incase of permanent impairment, until the condition has stabilized to alevel acceptable to the Sponsor/Investigator.

All SAEs and follow-up information must be reported to the Study Sponsorand clinical research organization (CRO) Medical Monitor within 24 hoursafter learning of the event and per instructions as included in theInvestigator Site File.

A listing of AEs and SAEs by subject is provided in the clinical studyreport (CSR).

Subject Discontinuation or Withdrawal

A study subject may withdraw or discontinue the study at any time andfor any reason. Reasons why a subject may discontinue or be withdrawnfrom the study include, but are not limited to, AE,parent(s)/guardian(s) request, investigator request, etc. When a subjectdiscontinues or is withdrawn from the study, the Investigator willcomplete all procedures designated for Visit 9 and notify the Sponsor.

APPENDIX 1A: ANTHROPOMETRY DATA COLLECTION PROCEDURES

All sites are trained on standardized techniques for the measure ofweight, length, and head circumference (Lohman, 1988).

Weight

Two people are involved with infant weight measures. One measurer willweigh the infant and read the weight as it is obtained. The othermeasurer will immediately note the measurement in the infant's chart.

The infant's clothing and diaper are removed. The infant should bepositioned in the center of the scale tray. Infants should be weighed tothe nearest 10 grams on a calibrated scale. Record the weight as soon asit is completed. Then the infant should be re-positioned and the weightmeasurement repeated and noted in writing. After the infant is removedfrom the scale tray, the weights should be compared, and they shouldagree within 10 grams. If the difference between the weights exceeds thetolerance limit of 10 grams, the infant should be re-positioned andreweighed a third time. The two weights that are within 10 grams of oneanother should be recorded. If there are NOT two weights within 10 gramsof one another, instrument error may be influencing the measure; theInvestigator should calibrate the scale, check the position of the scaleand infant, etc. and then re-weigh the infant.

Summary

-   -   Remove infant's clothing and diaper    -   Center infant on the scale tray    -   Weigh infant to nearest 10 grams    -   Write the weight on the infant's chart    -   Reposition and repeat weighing infant    -   Compare weights    -   Weight should agree within 10 grams (tolerance of the measure)        Length

Length is measured in the recumbent position with a calibratedlengthboard. The lengthboard must have 1) a fixed headpiece and 2) amoveable foot piece, which is perpendicular to the surface of the tablethat the length board is on.

Length measurements for infants should be obtained while the infant isdressed in light underclothing or a diaper. The infant's shoes must beremoved. Hair ornaments should be removed from the top of the head.

The infant should be placed on his/her back in the center of thelengthboard so that the infant is lying straight and his/her shouldersand buttocks are flat against the measuring surface. The infant's eyesshould be looking straight up. Both legs should be fully extended andthe toes should be pointing upward with feet flat against the footpiece.

Two people must be involved with infant length measures. One measurerholds the infant's head, with the infant looking vertically upward andthe crown of the head in contact with the headpiece in the FrankfortHorizontal Plane. The head of the infant is firmly but gently held inposition. The measurer gently cups the infant's ears while holding thehead in proper alignment. Make sure the infant's chin is not tucked inagainst his chest or stretched too far back.

While one measurer holds the infant's head in the proper position, thesecond measurer aligns the infant's trunk and legs, extends both legs,and brings the footpiece firmly against the heels. The measurer placesone hand gently but firmly on the infant's knees to maintain fullextension of the legs. The infant's toes are pointing upward with thesoles of the feet perpendicular to the horizontal backpiece of themeasuring device. It is imperative that both legs are fully extended foran accurate and reproducible length measurement.

The measurer at the feet should read aloud to the recorder the lengthmeasurement to the nearest cm. The length should be recorded on the dataform as soon as it is completed. Then the infant should be repositionedand the length measurement repeated and noted in writing. After theinfant is removed from the lengthboard, the length measurements shouldbe compared and they should agree within 0.5 cm.

If the difference between the two length measures exceeds 0.5 cm, theinfant should be repositioned and remeasured a third time. The thirdmeasure of length should be within 0.5 cm of either the first or secondlength measure; and the two measures within 0.5 cm should be recorded.If there are NOT two measures of length within 0.5 cm of one another,instrument error may be influencing the infantometer; the Investigatorshould calibrate the infantometer, re-position the infant and re-measurethe infant. The two measures that are within 0.5 cm of one anothershould be recorded.

SUMMARY

-   -   Use a calibrated lengthboard with a fixed headpiece and movable        footpiece which is perpendicular to the surface of the table    -   Measure infant without shoes and wearing light underclothing or        diaper    -   Measure length to 0.1 cm    -   Record measurement on chart    -   Reposition and remeasure infant    -   Measurements should agree to 0.5 cm        Head Circumference

The goal of the head circumference measure is to locate the maximumcircumference of the head. Head circumference or OFC (occipital frontalcircumference) is measured over the most prominent part on the back ofthe head (occiput) and just above the eyebrows (supraorbital ridges),i.e. the largest circumference of the head. Any braids, barrettes, orother hair decorations that will interfere with the measurement shouldbe removed. The infant may be held in the arms or on the lap of theparent/guardian if they prefer.

The tape is positioned across the frontal bones just above the eyebrows,above the ears, and around the biggest part of the back of the head (theocciput). The goal is to locate the maximum tissues. The measurement isread to the nearest 0.1 cm and recorded on the chart. The tape should berepositioned and the head circumference re-measured. The measures shouldagree within 0.2 cm. If the difference between the measures exceeds 0.2cm, the infant should be repositioned and re-measured a third time. Thetwo measures that are within 0.2 cm of one another should be recorded.

Summary

-   -   Use a flexible, non-stretchable tape    -   The goal is to locate the maximum circumference of the head    -   Position the tape just above the eyebrows on the supraorbital        ridge, above the ears, and around the biggest part on the back        of the head (the occiput)    -   Pull tape snugly to compress the hair    -   Read the measurement to the nearest 0.1 cm    -   Write measurement on the chart    -   Reposition tape and re-measure the head circumference    -   Measures should agree within 0.2 cm

APPENDIX 1B: FORMULA COMPOSITION

Building Enfamil Building Block Infant Block Nutritionals 0-12 monthsNutritionals (FORMULA- (Brand (FORMULA- 102 w/o Formula) 001 w/OPN) OPN)Nutrients/100 calories Protein, g 2 2.2 2.5 Fat, g 5.3 5.4 5.1 OPO Sn-2oil * 0.7 0.7 Carbohydrate, g 11.3 10.7 10.5 Dietary Fiber, mg ** 130.2330 Galactoligosaccharide, * 29.5 300 mg Polydextrose, mg ** 30 *Fructoligosaccharide, * 70.7 30 mg Linoleic Acid, mg 780 850 850Vitamins: Vitamin A, IU 300 300 300 Vitamin D, IU 60 60 60 Vitamin E, IU2 2 2 Vitamin K, mcg 9 9 9 Vitamin B1, mcg 80 80 80 Vitamin B2, mcg 140140 140 Vitamin B3, mcg 1000 1000 1000 Vitamin B6, mcg 60 60 60 VitaminB12, mcg 0.3 0.3 0.3 Folic acid, mcg 16 16 16 Pantothenic Acid, mcg 500600 600 Biotin, mcg 3 3 3 Vitamin C, mg 12 12 12 Minerals: Calcium, mg78 78 78 Phosphorus, mg 43 43 43 Magnesium, mg 8 8 8 Iron, mg 1.8 1.81.8 Zinc, mg 1 1.0 1 Manganese, mcg 15 15 15 Copper, mg 75 75 75 Iodine,mcg 15 10 15 Sodium, mg 27 27 27 Potassium, mg 108 108 108 Chloride, mg63 63 63 Selenium, mcg 2.8 2.8 2.8 Other: Choline, mg 24 24 24 Inositol,mg 6 6 6 B-carotene, mcg * 19 19 Lutein, mcg * 18 10 Nucleotides, mg **3.9 4 L-Carnitine, mg ** 1.4 1.3 Taurine, mg ** 5.8 6 Lactoferrin, mg *18 9 Docosahexaenoic acid ** 7.8 9.6 (DHA) mg Arachidonic acid ** 9.7 19(ARA) mg Data from Enfamil ™ Can Label Lot Number: ZP9L4H Expiration: 1Jun. 2021 *Not Added to Formula **Nutritional Information not available

APPENDIX 1C: FORMULA INGREDIENTS

Brand Formula

-   -   Nonfat Milk, Lactose, Vegetable Oil (Palm Olein, Coconut, Soy        and High Oleic Sunflower Oils), Whey protein concentrate and and        less than 2%: Galactoligosaccharides*, Polydextrose*,        Mortierella alpina Oil, Schizochytrium Sp. Oil, Calcium        Carbonate, Calcium Phosphate, Potassium citrate, Ferrous        sulfate, Potassium chloride, Magnesium oxide, Sodium chloride,        Zinc sulfate, Cupric Sulfate, Manganese sulfate, Potassium        Iodide, Sodium Selenite, Soy lecithin, Choline chloride,        Ascorbic acid, Niacinamide, Calcium Pantothenate, Vitamin A        palmitate, Vitamin B12, Vitamin D3, Riboflavin, Thiamin        Hydrochloride, Vitamin B6 Hydrochloride, Folic acid, Vitamin K1,        Biotin, Inositol, Vitamin E acetate, Taurine and L-Carnitine. *A        Type of Prebiotic**A Source of Arachidonic acid (ARA)**A Source        of Docosahexaenoic acid (DHA)

Formula-001 w/ OPN

-   -   Nonfat Milk, Lactose, Vegetable Oil (OPO Sn-2 Oil, Coconut, Soy        and High Oleic Sunflower Oils), Demineralized Whey, Whey protein        concentrate, Alpha lactlbumin, and less than 1% Polydextrose*,        Galactoligosaccharides*, Fructooligosaccharides*, Mortierella        alpina Oil Powder** Crypthecodinium Cohnii Oil Powder** Calcium        Carbonate, Dicalcium Phosphate, Potassium citrate, Ferrous        sulfate, Potassium chloride, Potassium Iodide, Magnesium        chloride, DiMagnesium phosphate, Sodium citrate, Zinc sulfate,        Copper Sulfate, Manganese sulfate, Sodium Selenite, Soy        lecithin, L-Choline bitartrate, Ascorbic acid, Niacinamide,        Calcium Pantothenate, Vitmin A palmitate, Vitamin B12, Vitamin        D3, Riboflavin, Thiamin Hydrochloride, Vitamin B6 Hydrochloride,        Folic acid, Vitamin K1, Biotin, Inositol, Vitamin E acetate,        Nucleotides (Cytidine 5′-monophosphate, Disodium Uridine        5′-monophosphate, Adenosine 5′-monophosphate, Disodium Guanosine        5′-monophosphate), Beta carotene, Lutein, Osteopontin,        Lactoferrin, Taurine and L-Carnitine *A Type of Prebiotic**A        Source of Arachidonic acid (ARA)**A Source of Docosahexaenoic        acid (DHA)

Formula-102 w/o OPN

-   -   Nonfat Milk, Lactose, Vegetable Oil (OPO Sn-2 Oil, Coconut, Soy        and High Oleic Sunflower Oils), Demineralized Whey, Whey protein        concentrate, Alpha lactlbumin, and less than 1%;        Galactoligosaccharides*, Fructooligosaccharides*, Mortierella        alpina**, Crypthecodinium Cohnii*** Calcium Carbonate, Calcium        Phosphate, Potassium citrate, Ferrous sulfate, Potassium        chloride, Potassium Iodide, Magnesium chloride, Magnesium        phosphate, Sodium citrate, Zinc sulfate, Copper Sulfate,        Manganese sulfate, Sodium Selenite, Soy lecithin, Choline        bitartrate, Ascorbic acid, Niacinamide, Calcium Pantothenate,        Vitamin A palmitate, Vitamin B12, Vitamin D3, Riboflavin,        Thiamin Hydrochloride, Vitamin B6 Hydrochloride, Folic acid,        Vitamin K1, Biotin, Inositol, Vitamin E acetate, Maltodextrin,        Nucleotides (Cytidine 5′-monophosphate, Disodium Uridine        5′-monophosphate, Adenosine 5′-monophosphate, Disodium Guanosine        5′-monophosphate), Beta carotene, Lutein, Lactoferrin, Taurine        and L-Carnitine *A Type of Prebiotic**A Source of Arachidonic        acid (ARA)***A Source of Docosahexaenoic acid (DHA)

APPENDIX 1F: STANDARDIZED DEFINITIONS FOR COMMON ADVERSE EVENTS

These AEs may or may not be related to formula tolerance (stooling,spit-up, crying, skin issues).

All AEs must be assigned an intensity score and causality (related ornot related to the investigational product; see section 18.1 fordetails).

ADVERSE EVENT DEFINITION Stooling Issues Difficulty having bowel Crying,fussing, or turning red when having a movement bowel movement Hardstools Healthcare professional diagnosis; pellet or hard rock-likestools Constipation Less than 3 bowel movements in 7 days Acute diarrheaRunny or watery stools for less than 2 weeks Chronic diarrhea Runny orwatery stools for more than 2 weeks or 3 separate episodes of acutediarrhea in 2 weeks Spit-up, Vomiting, GERD issues Regurgitation Milkcomes up into mouth but never out of mouth AND infant DOES NOT: archhis/her back as if in pain, stop drinking even if hungry, or cry,wheeze, or cough related to feedings Infantile spit up Milk comes out ofthe mouth after feeding (typically non- forceful), and the amount thatcomes out is less than half of the feeding volume; non- projectileVomiting Milk comes out of the mouth after feeding (typically forceful),and the amount that comes out is more than half of the feeding volumeGastroesophageal Baby arches his/her back as if in pain, stops drinkingeven if hungry, or Reflux Disease cries, wheezes or coughs related tofeedings (with or without milk coming (GERD) up into mouth) Cryingissues Crying/Neonatal abnormal Infant cries for 3 or more hours per daycrying Infantile colic/Infant colic Infant cries inconsolably for 3 ormore hours per day, at least 3 days per week, AND for at least 3 weeksSkin issues Diaper rash Contact/irritant dermatitis in the diaper area,with erythema and/or skin breakdown on the exposed convex skin surface(rate as Mild, Moderate, Severe using definitions outlined below) Mild:Baby has an area of pinkness in the diaper area Moderate: Baby hasdefinite pinkness in a large area with some small areas of definiteredness Severe: Baby has intense redness over a large area of theperianal region, or any area of redness with skin breakdown in thediaper area Atopic dermatitis/Eczema Any new skin lesions, not in thediaper area. Score for any erythema, edema/papulation, and/orexcoriation on scale from 0-3 each (9 points max). For each item, 0 =none, 1 = mild, 2 = moderate, 3 = severe. Mild: 1 or 2 points Moderate:3 to 5 points Severe: 6 to 9 points

APPENDIX 1G: EXEMPLARY FORMULA PREPARATION INSTRUCTIONS

This formula preparation instruction is appropriate for all Study InfantFormulas.

Proper hygiene, study formula preparation, dilution, use and storage areimportant to the well-being of your baby.

Ask your baby's doctor about the need to use cooled, boiled water whenpreparing the study formula and whether you need to boil utensils,bottles, nipples and rings in water before each use. If you areconcerned about lead or other harmful substances in your water, talk toyour healthcare professional before making study formula with tap water.

How to Mix Formula-001 Study Infant Formulas:

For proper mixing, follow these steps:

-   -   1. Wash your hands thoroughly with soap and warm water.    -   2. Following the measurement guidelines below, add the        appropriate amount of water and scoops of study formula powder        to the bottle:

Add scoop(s) of unpacked Finished Measure level powder using bottlewater enclosed scoop (approx.) 2 fl oz 1 scoop 2 fl oz 4 fl oz 2 scoops4 fl oz 6 fl oz 3 scoops 6 fl oz 8 fl oz 4 scoops 8 fl oz

-   -   3. Put the cap on the bottle and shake.    -   4. Feed prepared study formula immediately (within 2 hours of        preparation) or cover and store in the refrigerator for no        longer than 24 hours.        Expected Results

Administration of the nutritional formulas (e.g., prepared via Examples1, 1A, 1B, 2-1, 2-2, 2-3, 3) is expected to show one or more of thefollowing advantages, as compared to prior infant formulas: a) Increasedweight gain (grams/day) over 16 weeks of administration; b) Increasedvolume of infant formula intake (amount) over time; c) Increased infantgrowth: increased anthropometric measurements (head circumference gainvelocity, length gain velocity) and Z-scores (weight for age, length forage, weight for length for age, head circumference for age); d) Reducedmarkers of inflammation (tumor necrosis factor-alpha, interleukin 2, 4,5, 6, 8, 10, 12, 13, & 17; interleukin 2 receptor, interleukin 1 beta,and interferon gamma); e) Improved gastrointestinal tolerance (improveddigestion, stool composition, bowel movements, stool consistency, gas,reduced fussiness, supported development of flora in GI tract); f)Decreased adverse events; g) improved calcium absorption, improvedimmunity, improved bone strength, healthy gut microbiome, better sleep;h) supported development of brain, eye, and/or heart.

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Human milk oligosaccharides: every baby needs a sugar    mama. Glycobiology 2012; 22:1147-62.-   23. Brenna J T, Varamini B, Jensen R G, Diersen-Schade D A,    Boettcher J A, Arterburn L M. Docosahexaenoic and arachidonic acid    concentrations in human breast milk worldwide. Am J Clin Nutr. 2007;    85(6):1457-64.-   24. Brodbeck U, Denton W L, Tanahashi N, Ebner K E. The isolation    and identification of the B protein of lactose synthetase as    alpha-lactalbumin. J Biol Chem. 1967; 242: 1391-1397.-   25. Canfield L M, Clandinin M T, Davies D P, Fernandez M C, Jackson    J, Hawkes J, Goldman W J, Pramuk K, Reyes H, Sablan B, Sonobe T,    Bo X. Multinational study of major breast milk carotenoids of    healthy mothers. Eur J Nutr. 2003; 42(3):133-41.-   26. Capeding R, Gepanayao C P, Calimon N, Lebumfacil J, Davis A M,    Stouffer N, Harris B J. Lutein-fortified infant formula fed to    healthy term infants: evaluation of growth effects and safety.    Nutr J. 2010; 21; 9:22.-   27. Cheng J B, Wang J Q, Bu D P, Liu G L, Zhang C G, Wei H Y, et al.    Factors affecting the lactoferrin concentration in bovine milk. J    Dairy Sci. 2008; 91(3):970-6.-   28. Clandinin M, Chappell J, Leong S. Intrauterine fatty acid    accretion rates in human brain: implication for fatty acid    requirements. Early Hum Dev. 1980; 4:121-130.-   29. Clandinin M, Chappell J, Leong S. Extrauterine fatty acid    accretion rates in human brain: implication for fatty acid    requirements. Early Hum Dev. 1980; 4:131-138.-   30. Coppa G V, Pierani P, Zampini L, Carloni I, Carlucci A,    Gabrielli O. Oligosaccharides in human milk during different phases    of lactation. Acta Paediatr. 1999; 88(430):589-594.-   31. Davidson B, Meinzen-Derr J K, Wagner C L, Newburg D S, Morrow    A L. Fucosylated oligosaccharides in human milk in relation to    gestational age and stage of lactation. Adv Exp Med Biol. 2004;    5540:427-30.-   32. DHHS. (2000a, May 11, 2004). Growth chart training module.    Accurately Weighing and Measuring Infants, Children and Adolescents:    Technique. Health Resources and Services Agency, Maternal and Child    Health Bureau. Retrieved Feb. 3, 2017, from the World Wide Web:    http://www.cdc.govinccdphp/dnpa/growthcharts/training/modules/modules.htm-   33. Dupont C, Rivero M, Grillon C, Belaroussi N, Kalindjian A,    Marin V. Eur J Clin Nutr. 2010 July; 64(7):765-7.-   34. Fleisler S, Anderson R E. Chemistry and metabolism of lipids in    the vertebrate retina. Prog Lipid Res. 1983; 22:79-131.-   35. Innis SM1, Dyer R, Nelson C M. Evidence that palmitic acid is    absorbed as sn-2 monacylglycerol from human milk by breast-fed    infants. Lipids. 1994; 29(8):541-5.-   36. Jackson J G, Janszen D B, Lonnerdal B, Lien E L, Pramuk K P,    Kuhlman C F. A multinational study of alpha-lactalbumin    concentration in human milk. J Nutr Biochem. 2004; 15: 517-521.-   37. Johnston W H, Ashley C, Yeiser M, Harris C L, Stolz S I, Wampler    J L, Wittke A, and Cooper T A. Growth and tolerance of formula with    lactoferrin in infants through one year of age: double-blind,    randomized, controlled trial. BMC Pediatr. 2015; 15: 173.-   38. Kennedy K I, Fewtrell M S, Morley R, Abbott R, Quinlan P T,    Wells J C, Bindels J G, Lucas A. Double-blind, randomized trial of a    synthetic triacylglycerol in formula-fed term infants: effect on    stool biochemistry, stool characteristics, and bone mineralization.    Am J Clin Nutr. 1999 November; 70(5):920-7.-   39. King J, Cummings G, Guo N, Trivedi L, Readmond B, Keane V, et    al. A double-blind, placebo-controlled, pilot study of bovine    lactoferrin supplementation in bottle-fed infants. J Pediatr    Gastroentrol Nutr. 2007; 44:245-51.-   40. Krinsky N I, Johnson E J. Carotenoid actions and their relation    to health and disease. Mol Aspects Med. 2005; 26(6):459-516.-   41. Landrum J T, Bone R A. 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Lonnerdal B. Infant formula and infant nutrition: bioactive    proteins of human milk and implications for composition of infant    formulas. Am J Clin Nutr. 2014; 99(3):7125-75.-   48. Makrides M, Neumann M A, Simmer K, Gibson R A. A critical    appraisal of the role of dietary long-chain polyunsaturated fatty    acids on neural indices of term infants: a randomized, controlled    trial. Pediatrics. 2000; 105(1 pt 1):32-38.-   49. Manzoni P, Stolfi I, Messner H, Cattani S, Laforgia N, Romeo M    G, Bollani L, Rinaldi M, Gallo E, Quercia M, Maule M, Mostert M,    Decembrino L, Magaldi R, Mosca F, Vagnarelli F, Memo L, Betta P M,    Stronati M, Farina D, Italian Task Force for the Study and    Prevention of Neonatal Fungal Infections—the Italian Society of    Neonatology. Bovine lactoferrin prevents invasive fungal infections    in very low birth weight infants: a randomized controlled trial.    Pediatrics. 2012 January; 129(1):116-23.-   50. Moro G, Minoli I, Mosca M, Fanaro S, Jelinek J, Stahl B,    Boehm G. Dose-related bifidogenic effects of galacto- and    fructo-oligosaccharides in formula-fed term infants. J Pediatr    Gastroenterol Nutr. 2002 March; 34(3):291-5.-   51. Nelson S E, Rogers R R, Ziegler E E, Fomon S J: Gain in weight    and length during early infancy. Early Human Development. 1989; 19    (4):223-239.-   52. Neuringer M, Connor W, Lin D, Barstad L, Luck S. Biochemical and    functional effects of prenatal and postnatal ω-3 fatty acid    deficiency on retina and brain in rhesus monkeys. Proc Natl Acad    Sci. 1989; 83:285-294.-   53. Ochoa T J, Cleary T G. Effect of lactoferrin on enteric    pathogens. Biochimie. 2009; 91(1):30-34.-   54. O'Connor D L, Hall R, Adamkin D, et al. Ross Preterm Lipid Study    Growth and development in preterm infants fed long-chain    polyunsaturated fatty acids: a prospective, randomized controlled    trial. Pediatrics. 2001; 108(2):359-371-   55. Roberfroid M. 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EQUIVALENTS AND SCOPE

In the claims, articles such as “a,” “an,” and “the” may mean one ormore than one unless indicated to the contrary or otherwise evident fromthe context. Claims or descriptions that include “or” between one ormore members of a group are considered satisfied if one, more than one,or all of the group members are present in, employed in, or otherwiserelevant to a given product or process unless indicated to the contraryor otherwise evident from the context. The invention and/or presentdisclosure includes embodiments in which exactly one member of the groupis present in, employed in, or otherwise relevant to a given product orprocess. The invention and/or present disclosure includes embodiments inwhich more than one, or all of the group members are present in,employed in, or otherwise relevant to a given product or process.

Furthermore, the invention and/or present disclosure encompasses allvariations, combinations, and permutations in which one or morelimitations, elements, clauses, and descriptive terms from one or moreof the listed claims is introduced into another claim. For example, anyclaim that is dependent on another claim can be modified to include oneor more limitations found in any other claim that is dependent on thesame base claim. Where elements are presented as lists, e.g., in Markushgroup format, each subgroup of the elements is also disclosed, and anyelement(s) can be removed from the group. It should it be understoodthat, in general, where the invention and/or present disclosure, oraspects of the invention and/or present disclosure, is/are referred toas comprising particular elements and/or features, certain embodimentsof the invention and/or present disclosure or aspects of the inventionand/or present disclosure consist, or consist essentially of, suchelements and/or features. For purposes of simplicity, those embodimentshave not been specifically set forth in haec verba herein. It is alsonoted that the terms “comprising” and “containing” are intended to beopen and permits the inclusion of additional elements or steps. Whereranges are given, endpoints are included. Furthermore, unless otherwiseindicated or otherwise evident from the context and understanding of oneof ordinary skill in the art, values that are expressed as ranges canassume any specific value or sub-range within the stated ranges indifferent embodiments of the invention and/or present disclosure, to thetenth of the unit of the lower limit of the range, unless the contextclearly dictates otherwise.

This application refers to various issued patents, published patentapplications, journal articles, and other publications, all of which areincorporated herein by reference. If there is a conflict between any ofthe incorporated references and the instant specification, thespecification shall control. In addition, any particular embodiment ofthe present invention and/or present disclosure that falls within theprior art may be explicitly excluded from any one or more of the claims.Because such embodiments are deemed to be known to one of ordinary skillin the art, they may be excluded even if the exclusion is not set forthexplicitly herein. Any particular embodiment of the invention and/orpresent disclosure can be excluded from any claim, for any reason,whether or not related to the existence of prior art.

Those skilled in the art will recognize or be able to ascertain using nomore than routine experimentation many equivalents to the specificembodiments described herein. The scope of the present embodimentsdescribed herein is not intended to be limited to the above Description,but rather is as set forth in the appended claims. Those of ordinaryskill in the art will appreciate that various changes and modificationsto this description may be made without departing from the spirit orscope of the present invention and/or present disclosure, as defined inthe following claims.

What is claimed is:
 1. A reconstituted, ready-to-use nutritional formulacomprising: a) approximately 0.25 grams to approximately 5.0 grams ofalpha-lactalbumin enriched whey protein concentrate per L ofreconstituted, ready-to-use nutritional formula, wherein thereconstituted, ready-to-use nutritional formula comprises at least 30%alpha-lactalbumin by weight of the alpha-lactalbumin enriched wheyprotein concentrate; b) approximately 0.02 grams to approximately 1.0grams of lactoferrin per L of reconstituted, ready-to-use nutritionalformula; c) approximately 1.0 grams to approximately 14.0 grams of oleicacid-palmitic acid-oleic acid triglyceride (OPO triglyceride) per L ofreconstituted, ready-to-use nutritional formula, wherein palmitic acidis at the SN-2 position of the glycerol backbone of the OPOtriglyceride; d) approximately 35 grams to approximately 80 grams oflactose per L of the reconstituted, ready-to-use nutritional formula; e)approximately 60 micrograms to approximately 0.05 grams of lutein per Lof the reconstituted, ready-to-use nutritional formula; f)docosahexanoic acid; g) approximately 0.1 grams to approximately 1.0grams of arachidonic acid per L of the reconstituted, ready-to-usenutritional formula; h) approximately 2.0 grams to approximately 5.0grams of galactooligosaccharides per L of the reconstituted,ready-to-use nutritional formula; and i) approximately 0.1 grams toapproximately 0.5 grams of fructooligosaccharides per L of thereconstituted, ready-to-use nutritional formula; wherein thereconstituted, ready-to-use nutritional formula does not comprisepolydextrose.
 2. The reconstituted, ready-to-use nutritional formula ofclaim 1 further comprising linoleic acid.
 3. The reconstituted,ready-to-use nutritional formula of claim 1 further comprisingalpha-linolenic acid.
 4. The reconstituted, ready-to-use nutritionalformula of claim 1 further comprising vitamins, minerals, nucleotides,or a combination thereof.
 5. The reconstituted, ready-to-use nutritionalformula of claim 1 further comprising L-choline bitartrate, L-carnitine,or a combination thereof.
 6. The reconstituted, ready-to-use nutritionalformula of claim 1 further comprising soya lecithin.
 7. Thereconstituted, ready-to-use nutritional formula of claim 1 furthercomprising beta-carotene, taurine, or a combination thereof.
 8. Thereconstituted, ready-to-use nutritional formula of claim 4, wherein thenucleotides are selected from the group consisting of adenosine 5‘-monophosphate, cytidine 5’-monophosphate, guanosine 5 ‘-monophosphate,uridine 5’-monophosphate, or a combination thereof.
 9. Thereconstituted, ready-to-use nutritional formula of claim 1, wherein thereconstituted, ready-to-use nutritional formula comprises approximately0.5 grams to approximately 4.2 grams of alpha-lactalbumin enriched wheyprotein concentrate per L of reconstituted, ready-to-use nutritionalformula.
 10. The reconstituted, ready-to-use nutritional formula ofclaim 1, wherein the reconstituted, ready-to-use nutritional formulacomprises approximately 0.02 grams to approximately 0.10 grams oflactoferrin per L of reconstituted, ready-to-use nutritional formula.11. The reconstituted, ready-to-use nutritional formula of claim 1,wherein the reconstituted, ready-to-use nutritional formula comprisesapproximately 3.0 grams to approximately 7.0 grams of the oleicacid-palmitic acid-oleic acid triglyceride per L of reconstituted,ready-to-use nutritional formula.
 12. The reconstituted, ready-to-usenutritional formula of claim 1, wherein the reconstituted, ready-to-usenutritional formula comprises approximately 0.00006 grams toapproximately 0.021 grams of lutein per L of reconstituted, ready-to-usenutritional formula.
 13. The reconstituted, ready-to-use nutritionalformula of claim 1, wherein the reconstituted, ready-to-use nutritionalformula comprises approximately 0.05 grams to approximately 0.09 gramsof docosahexanoic acid per L of reconstituted, ready-to-use nutritionalformula.
 14. The reconstituted, ready-to-use nutritional formula ofclaim 1, wherein the reconstituted, ready-to-use nutritional formulacomprises approximately 0.1 grams to approximately 0.50 grams ofarachidonic acid per L of reconstituted, ready-to-use nutritionalformula.
 15. The reconstituted, ready-to-use nutritional formula ofclaim 1, wherein the reconstituted, ready-to-use nutritional formulacomprises approximately 2.0 grams to approximately 4.1 grams ofgalactooligosaccharides per L of reconstituted, ready-to-use nutritionalformula.
 16. The reconstituted, ready-to-use nutritional formula ofclaim 1, wherein the reconstituted, ready-to-use nutritional formulacomprises approximately 0.2 grams to approximately 0.4 grams offructooligosaccharides per L of reconstituted, ready-to-use nutritionalformula.
 17. The reconstituted, ready-to-use nutritional formula ofclaim 1, wherein the reconstituted, ready-to-use nutritional formulacomprises approximately 2.2 grams to approximately 4.5 grams ofprebiotics per L of reconstituted, ready-to-use nutritional formula,wherein the prebiotics comprise galactooligosaccharides,fructooligosaccharides, or a combination thereof.
 18. The reconstituted,ready-to-use nutritional formula of claim 1 wherein the reconstituted,ready-to-use nutritional formula comprises approximately 65 grams toapproximately 80 grams of lactose per L of reconstituted, ready-to-usenutritional formula.
 19. The reconstituted, ready-to-use nutritionalformula of claim 2, wherein the reconstituted, ready-to-use nutritionalformula comprises approximately 5.3 grams to approximately 6.3 grams oflinoleic acid per L of reconstituted, ready-to-use nutritional formula.20. A dehydrated powder form of a nutritional formula comprising: a)approximately 0.18 grams to approximately 3.7 grams of alpha-lactalbuminenriched whey protein concentrate per 100 grams of the dehydrated powderform of the nutritional formula, wherein the dehydrated powder form ofthe nutritional formula comprises at least 30% alpha-lactalbumin byweight of the alpha-lactalbumin enriched whey protein concentrate; b)approximately 0.015 grams to approximately 0.74 grams of lactoferrin per100 grams of the dehydrated powder form of nutritional formula; c)approximately 0.74 grams to approximately 10.4 grams of oleicacid-palmitic acid-oleic acid triglyceride (OPO triglyceride) per 100grams of the dehydrated powder form of the nutritional formula, whereinpalmitic acid is at the SN-2 position of the glycerol backbone of theOPO triglyceride; d) approximately 26 grams to approximately 59 grams oflactose per 100 grams of the dehydrated powder form of the nutritionalformula; e) approximately 44 micrograms to approximately 0.037 grams oflutein per 100 grams of the dehydrated powder form of the nutritionalformula; f) docosahexanoic acid; g) approximately 0.074 grams toapproximately 0.74 grams of arachidonic acid per 100 grams of thedehydrated powder form of the nutritional formula; h) approximately 1.5grams to approximately 3.7 grams of galactooligosaccharides per 100grams of the dehydrated powder form of the nutritional formula; and i)approximately 0.074 grams to approximately 0.37 grams offructooligosaccharides per 100 grams of the dehydrated powder form ofthe nutritional formula; wherein the dehydrated powder form of thenutritional formula does not comprise polydextrose.
 21. Thereconstituted, ready-to-use nutritional formula of claim 1 comprisingthe following weight ranges, in grams per liter (g/L) of reconstituted,ready-to-use nutritional formula: a) approximately 3 grams toapproximately 10 grams whey protein concentrate that is notalpha-lactalbumin enriched, per L of the reconstituted, ready-to-usenutritional formula; b) approximately 2.5 grams to approximately 3.0grams of alpha-lactalbumin enriched whey protein concentrate per L ofthe reconstituted, ready-to-use nutritional formula; c) approximately20.0 grams to approximately 30.0 grams of demineralized whey per L ofthe reconstituted, ready-to-use nutritional formula; d) approximately16.5 grams to approximately 18.5 grams of skimmed milk powder per L ofthe reconstituted, ready-to-use nutritional formula; e) approximately0.02 grams to approximately 0.17 grams of lactoferrin per L of thereconstituted, ready-to-use nutritional formula; f) approximately 30.0grams to approximately 42.0 grams of a vegetable oil blend comprisingthe oleic acid-palmitic acid-oleic acid triglyceride; in whichapproximately 3.0 grams to approximately 7.0 grams of the vegetable oilblend is oleic acid-palmitic acid-oleic acid triglyceride per L of thereconstituted, ready-to-use nutritional formula; g) approximately 65grams to approximately 80 grams of lactose per L of the reconstituted,ready-to-use nutritional formula; h) approximately 0.00006 grams toapproximately 0.025 grams of lutein per L of the reconstituted,ready-to-use nutritional formula; i) approximately 0.05 grams toapproximately 0.09 grams of docosahexanoic acid per L of thereconstituted, ready-to-use nutritional formula; j) approximately 0.1grams to approximately 0.5 grams of arachidonic acid per L of thereconstituted, ready-to-use nutritional formula; k) approximately 5grams to approximately 6.2 grams linoleic acid per L of thereconstituted, ready-to-use nutritional formula; l) approximately 0.25grams to approximately 0.6 grams alpha-linolenic acid per L of thereconstituted, ready-to-use nutritional formula; m) approximately 2.0grams to approximately 5.0 grams of galactooligosaccharides per L of thereconstituted, ready-to-use nutritional formula; n) approximately 0.10grams to approximately 0.50 grams of fructooligosaccharides per L of thereconstituted, ready-to-use nutritional formula; o) approximately 0.05grams to approximately 0.15 grams of Vitamin C per L of thereconstituted, ready-to-use nutritional formula; approximately 0.001grams to approximately 0.05 grams of Vitamin E per L of thereconstituted, ready-to-use nutritional formula; approximately 0.01grams to approximately 0.05 grams of inositol per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0005grams to approximately 0.02 grams of Vitamin A per L of thereconstituted, ready-to-use nutritional formula approximately 0.005grams to approximately 0.009 grams of niacin per L of the reconstituted,ready-to-use nutritional formula; approximately 0.00001 grams toapproximately 0.006 grams of Vitamin D3 per L of the reconstituted,ready-to-use nutritional formula; approximately 0.001 grams toapproximately 0.005 grams of pantothenic acid per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0005grams to approximately 0.0015 grams of Vitamin K1 per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0005grams to approximately 0.0015 grams of Vitamin B1 per L of thereconstituted, ready-to-use nutritional formula; approximately 0.00001grams to approximately 0.001 grams of Vitamin B2 per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0001grams to approximately 0.0008 grams of Vitamin B6 per L of thereconstituted, ready-to-use nutritional formula; approximately 0.0001grams to approximately 0.002 grams of folic acid per L of thereconstituted, ready-to-use nutritional formula; approximately 0.00001grams to approximately 0.004 grams of biotin per L of the reconstituted,ready-to-use nutritional formula; and approximately 0.000001 grams toapproximately 0.0005 grams of Vitamin B12 per L of the reconstituted,ready-to-use nutritional formula; p) approximately 0.5 grams toapproximately 0.8 grams of dicalcium phosphate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.3 gramsto approximately 0.8 grams of calcium carbonate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.3 gramsto approximately 0.5 grams of potassium chloride per L of thereconstituted, ready-to-use nutritional formula; approximately 0.4 gramsto approximately 0.7 grams of tripotassium citrate monohydrate per L ofthe reconstituted, ready-to-use nutritional formula; approximately 0.3grams to approximately 0.5 grams of sodium citrate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.2 gramsto approximately 0.5 grams of trisodium citrate dihydrate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.002grams to approximately 0.006 grams of dimagnesium phosphate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.00002grams to approximately 0.00005 grams of sodium selenite per L of thereconstituted, ready-to-use nutritional formula; approximately 0.02grams to approximately 0.06 grams of iron (II) sulfate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.01grams to approximately 0.03 grams of zinc sulfate per L of thereconstituted, ready-to-use nutritional formula; approximately 0.001grams to approximately 0.004 grams of copper sulfate per L of thereconstituted, ready-to-use nutritional formula; and approximately 0.001grams to approximately 0.0045 grams of manganese (II) sulfate per L ofthe reconstituted, ready-to-use nutritional formula; q) approximately0.05 grams to approximately 0.1 grams of adenosine 5′-monophosphate perL of the reconstituted, ready-to-use nutritional formula; approximately0.01 grams to approximately 0.03 grams of cytidine 5′-monophosphate perL of the reconstituted, ready-to-use nutritional formula; approximately0.001 grams to approximately 0.006 grams of guanosine 5′-monophosphateper L of the reconstituted, ready-to-use nutritional formula; andapproximately 0.01 grams to approximately 0.03 grams of uridine5′-monophosphate per L of the reconstituted, ready-to-use nutritionalformula; r) approximately 0.1 grams to approximately 0.5 grams ofL-choline bitartrate per L of the reconstituted, ready-to-usenutritional formula; approximately 0.005 grams to approximately 0.03grams of L-carnitine per L of the reconstituted, ready-to-usenutritional formula; s) approximately 0.0001 grams to approximately0.0007 grams of beta-carotene per L of the reconstituted, ready-to-usenutritional formula; approximately 0.03 grams to approximately 0.07grams of taurine per L of the reconstituted, ready-to-use nutritionalformula; and t) approximately 0.3 grams to approximately 0.5 grams ofsoya lecithin per L of the reconstituted, ready-to-use nutritionalformula.
 22. A method of providing nutrition to a subject, wherein themethod comprises: administering the reconstituted, ready-to-usenutritional formula of claim 1 to the subject.
 23. A method of providingnutrition to a subject, wherein the method comprises: i. reconstitutingthe dehydrated powder form of the nutritional formula of claim 20 withwater to form a reconstituted, ready-to-use nutritional formula; and ii.administering the reconstituted, ready-to-use nutritional formula to thesubject.
 24. A kit comprising: i. one or more packages of the dehydratedpowder form of the nutritional formula of claim 20; and ii. instructionsfor reconstituting the nutritional formula by adding water andadministering the nutritional formula to a subject.
 25. Thereconstituted, ready-to-use nutritional formula of claim 1, comprising:a) approximately 2.7 grams of alpha-lactalbumin enriched whey proteinconcentrate per L of reconstituted, ready-to-use nutritional formula; b)approximately 63 milligrams of lactoferrin per L of reconstituted,ready-to-use nutritional formula; c) approximately 4.8 grams of oleicacid-palmitic acid-oleic acid triglyceride (OPO triglyceride) per L ofreconstituted, ready-to-use nutritional formula; d) approximately 66grams of lactose per L of the reconstituted, ready-to-use nutritionalformula; e) approximately 70 micrograms of lutein per L of thereconstituted, ready-to-use nutritional formula; f) approximately 68milligrams of docosahexanoic acid per L of the reconstituted,ready-to-use nutritional formula; g) approximately 135 milligrams ofarachidonic acid per L of the reconstituted, ready-to-use nutritionalformula; h) approximately 2.1 grams of galactooligosaccharides per L ofthe reconstituted, ready-to-use nutritional formula; and i)approximately 211 milligrams of fructooligosaccharides per L of thereconstituted, ready-to-use nutritional formula.
 26. The dehydratedpowder form of the nutritional formula of claim 20, comprising: a)approximately 2.0 grams of alpha-lactalbumin enriched whey proteinconcentrate per 100 grams of the dehydrated powder form of thenutritional formula; b) approximately 47 milligrams of lactoferrin per100 grams of the dehydrated powder form of nutritional formula; c)approximately 3.6 grams of oleic acid-palmitic acid-oleic acidtriglyceride (OPO triglyceride) per 100 grams of the dehydrated powderform of the nutritional formula; d) approximately 49 grams of lactoseper 100 grams of the dehydrated powder form of the nutritional formula;e) approximately 52 micrograms of lutein per 100 grams of the dehydratedpowder form of the nutritional formula; f) approximately 50 milligramsof docosahexanoic acid per 100 grams of the dehydrated powder form ofthe nutritional formula; g) approximately 100 milligrams of arachidonicacid per 100 grams of the dehydrated powder form of the nutritionalformula; h) approximately 1.56 grams of galactooligosaccharides per 100grams of the dehydrated powder form of the nutritional formula; and i)approximately 156 milligrams of fructooligosaccharides per 100 grams ofthe dehydrated powder form of the nutritional formula.
 27. Thereconstituted, ready-to-use nutritional formula of claim 1, wherein thereconstituted, ready-to-use nutritional formula comprises approximately0.001 grams to approximately 0.12 grams of docosahexanoic acid per L ofreconstituted, ready-to-use nutritional formula.
 28. The reconstituted,ready-to-use nutritional formula of claim 21 comprising approximately0.00001 grams to approximately 0.00005 grams of maltodextrin per L ofthe reconstituted, ready-to-use nutritional formula.